cdc hicpac guideline for infection prevention in …...2013/06/05 · antimicrobial agent, when...

Healthcare Infection Control Practices Advisory Committee Meeting

June 5, 2013

CDC and HICPAC DRAFT Guideline for

Prevention of Surgical Site Infection

Disclaimer: The findings and conclusions are draft and have not been formally disseminated

by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy.

Objectives

Achievements since March 2013

Grading/Quality of Evidence/Formulating Recommendations

Core and Arthroplasty DRAFT Recommendations

Achievements since March

Evidence and GRADE Tables, Narrative Summaries, Recommendations

CORE

Updated: AMP parenteral and topical, Glycemic control, Normothermia, Oxygenation, Skin preparation

NEW Topic- Skin preparation: Preoperative bathing

Arthroplasty

Updated Recommendations: Exhaust Suit

New Recommendations: Transfusion, Immunosuppressive therapy, Anticoagulation, Antimicrobial prophylaxis in presence of a drain,

New Topic: Biofilm

Type of

evidence

Initial

grade

Criteria to decrease grade Criteria to increase grade Overall

quality

grade

RCT High Study quality limitations

Serious (-1) or very serious

(-2) study quality limitations

Inconsistency

Important inconsistency (-1)

Indirectness

Some (-1) or major

(-2) uncertainty about directness

Imprecision

Imprecise or sparse data (-1)

Publication bias

High risk of bias (-1)

Strength of Association

Strong (+1) or very strong

evidence of association (+2)

Dose-Response

Evidence of a dose-response

gradient (+1)

Confounding

Inclusion of unmeasured

confounders increases the

magnitude of effect

(+1)

High

Moderate

Observational

study

Low Low

Any other

evidence

(e.g. expert

opinion)

Very

low

Very Low

Grading the Evidence

Overall Quality Grades

High – Further research is very unlikely to change confidence in the estimate of

effect

Moderate – Further research is likely to impact confidence in the estimate of effect and

may change the estimate

Low – Further research is very likely to impact confidence in the estimate of effect

and is likely to change the estimate

Very low – Any estimate of effect

FORMULATING

RECOMMENDATIONS

Formulating Recommendations

Three key inputs: • Values and preferences used to determine the “critical”

outcomes

• Overall GRADE of the evidence for the “critical” outcomes

• Net benefits, net harms, or trade-offs that result from weighing

the "critical" outcomes

Recommendations • For or against (direction)

• Strong or weak (strength)

CDC and HICPAC -Updated Categorization Scheme

for Recommendations

http://www.cdc.gov/hicpac/pdf/guidelines/2009-10-29HICPAC_GuidelineMethodsFINAL.pdfor

Umscheid CA, et al. , Am J Infect Control 2010;38:264-73.

Category IA

Category IB

Category IC

Category II

No recommendation

/unresolved issue

A strong recommendation supported by high to moderate quality

evidence suggesting net clinical benefits or harms.

A strong recommendation supported by low-quality evidence suggesting

net clinical benefits or harms, or an accepted practice (e.g., aseptic

technique) supported by low to very low-quality evidence.

A strong recommendation required by state or federal regulation

A weak recommendation supported by any quality evidence suggesting a

tradeoff between clinical benefits and harms.

An unresolved issue for which there is low to very low-quality evidence

with uncertain tradeoffs between benefits and harms.

DRAFT RECOMMENDATIONS

CORE SECTION

Q1. PARENTERAL

ANTIMICROBIAL PROPHYLAXIS

(AMP)

Q1. What are the most effective strategies for

administering parenteral AMP to reduce the risk of SSI?

Q1A. Timing

• Q1A.1 Cesarean section

Q1B. Weight-based dosing

Q1C. Intraoperative redosing

Q1D. Postoperative duration

Disclaimer: The findings and conclusions are draft and have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed

to represent any agency determination or policy.

Q1A. PREOPERATIVE AMP TIMING

Q1A. How does the timing of preoperative AMP impact

the risk of SSI and what is the optimal timing?

Draft recommendations

JUNE 2013 UPDATED

1A. Administer by the intravenous route a single dose of the prophylactic

antimicrobial agent. For most prophylactic agents, administration should be

within 60 minutes prior to incision. Administer vancomycin and

fluoroquinolones within 60-120 minutes prior to incision. (Category IB)

MARCH 2013: Administer by the intravenous route a single dose of the prophylactic antimicrobial

agent within 60 minutes prior to surgical incision. Administer vancomycin and fluoroquinolones within

60-120 minutes prior to surgical incision. (Category IB)



Q1A. How does the timing of preoperative AMP impact

the risk of SSI and what is the optimal timing?

1999 Guideline: Administer by the intravenous route the initial dose of prophylactic

antimicrobial agent, timed such that a bactericidal concentration of the drug is established

in serum and tissues when the incision is made. (Category IA)

2002 Surgical Care Improvement Project (SCIP)

2012 The Medical Letter -Surgical Prophylaxis Guidelines

2013 American Society of Health-System Pharmacists (ASHP) Guidelines

Single IV dose AMP within 60 minutes before the procedure.

Vancomycin or a fluoroquinolone within 60-120 minutes before the initial incision (for

adequate tissue levels at the time of incision and to minimize the possibility of an

infusion reaction close to the time of induction of anesthesia)



Clinical Practice Guidelines

Q1A.1 CESAREAN SECTION

AMP TIMING

Q1A.1 In Cesarean section, how does the timing of AMP

impact the risk of SSI and what is the optimal timing?

Draft Recommendations

MARCH and JUNE 2013

1A.1. Administer the appropriate single dose parenteral prophylactic

antimicrobial agent within 60 minutes prior to skin incision in all cesarean

sections. (Category IA)


1999 Guideline For high-risk cesarean section AMP after the umbilical cord is clamped.

2011 American College of Obstetricians and Gynecologists (ACOG)

2012 The Medical Letter -Surgical Prophylaxis Guidelines


AMP for all cesarean deliveries, unless already on antimicrobial treatment (e.g., for

chorioamnionitis) should be administered within 60 minutes before the start of the

cesarean delivery.



Q1B. WEIGHT-ADJUSTED DOSING

Q1B. How safe and effective is weight-based dosing and

re-dosing of AMP in non-obese, obese, and morbidly

obese patients? Draft recommendations

JUNE 2013 UPDATED

1B. In obese and morbidly obese patients, dose the prophylactic

antimicrobial agent based on the patient’s weight where pharmacokinetic

data support it (e.g., cefazolin, vancomycin, and aminoglycosides).

(Category 1B)

MARCH 2013 Adjust the prophylactic antimicrobial agent dose, based on the patient’s weight, in

obese and morbidly obese patients. (Category 1B)



Q1B. How safe and effective is weight-based dosing and

re-dosing of AMP in non-obese, obese, and morbidly

obese patients?

2007 Society for Thoracic Surgeons

cefazolin 2 g if > 60 kg

vancomycin15 mg/kg

aminoglycoside (usually gentamicin, 4 mg/kg)..

2012 Treatment Guidelines from The Medical Letter – Surgical Prophylaxis

cefazolin 2 g if >80kg . Morbidly obese may need higher doses

vancomycin15 mg/kg of vancomycin if >75 kg (up to a maximum of 1.5 g)


cefazolin 2 g if >80kg; 3 g if >120 kg

gentamicin: If >20% above ideal body weight, calculate dose using the ideal body

weight plus 40% of the difference between the actual and ideal weights. If in

combination with a parenteral anaerobic agents use 4.5–5 mg/kg as a single dose.




Q1C. INTRAOPERATIVE REDOSING

Q1C. How safe and effective is intraoperative redosing

and when is it indicated? Draft recommendations

JUNE 2013 UPDATED

1C. Maintain therapeutic levels of the prophylactic antimicrobial agent in serum and tissues

throughout the operation based on individual agent pharmacokinetics. (Category IB)

1C.1. Redose intraoperatively when the procedure duration exceeds the half-life of the

antimicrobial agent, when there is excessive blood loss (i.e., >1500 ml) or in cases of

extensive burns. (Category IB)

1C.2. Redose at intervals 1-2 times the prophylactic antimicrobial agent half-life, measured

starting at the beginning of the single preoperative dose. (Category IB)

1C.3. No recommendation can be made regarding use of weight-based dosing when re-

dosing obese and morbidly obese patients (No recommendation/unresolved issue)

MARCH 2013: Maintain therapeutic levels of the prophylactic antimicrobial agent in serum and

tissues throughout the operation based on individual agent pharmacokinetics; redose when the

procedure duration exceeds the half-life of the antimicrobial agent, or when there is excessive blood

loss. (Category IB)




and when is it indicated? Draft Recommendations

JUNE 2013 UPDATE QUESTIONS

1C.1. Redose intraoperatively when the procedure duration exceeds the

half-life of the antimicrobial agent, when there is excessive blood loss

(i.e., >1500 ml) or in cases of extensive burns. (Category IB)

Questions:

Redose: Should we specify redosing only for short-acting agents?

Excessive blood loss (i.e., >1500ml): Should we specific level?




and when is it indicated?


1999 Guideline: Maintain therapeutic levels of the agent in serum and tissues throughout

the operation (Category IA)


cefazolin- every 3 to 4 hours in patients with normal renal function.

vancomycin - 7.5 mg/kg may be considered during cardiopulmonary bypass,

(usefulness is not well established)

aminoglycoside -during cardiopulmonary bypass not indicated/may be harmful

2008 NICE: When the operation is longer than the half-life of the antibiotic

2010 Society of Obstetricians and Gynaecologists of Canada

If an open abdominal procedure is lengthy (> 3 hours) or estimated blood loss is greater

than 1500 mL, redose 3-4 hours after the initial dose




and when is it indicated?



In procedures >3 hours, with major blood loss, or in patients with extensive burns,

redose at intervals 1-2 times the half-life of the drug …for the duration of the procedure

in patients with normal renal function.


For short-half life agents- if procedure duration exceeds the recommended redosing

interval, if prolonged or excessive bleeding (i.e., >1500 mL),or other factors that may

shorten the half-life of the prophylactic agent (e.g., extensive burns).

In patients in whom the half-life of the agent may be prolonged (e.g., patients with renal

insufficiency or failure) redosing may not be warranted.



Q1D. POSTOPERATIVE AMP DURATION

Q1D. How safe and effective is postoperative AMP,

when is it indicated and what is the optimal duration?

Evidence Summary

“Duration”= number of hours or days AMP was continued after the skin

incision was closed the operating room

• Single preoperative dose ± intraoperative redosing NOT included in calculation

39 studies comparing same agents, IV AMP both arms

• 74% published before 1999

Critical Outcome: SSI* (superficial, deep and organ/space)



1D. How safe and effective is postoperative AMP, when

is it indicated and what is the optimal duration?


JUNE 2013 UPDATED

1D. In clean and clean-contaminated procedures, do not administer

additional prophylactic antimicrobial agent doses after the surgical incision is

closed in the operating room. (Category IA)

1D.1. In cardiac procedures, discontinue prophylactic antimicrobial agents

≤24 hours after the surgical incision is closed in the operating room.

(Category II)

March 2013: In clean and clean-contaminated procedures, do not administer additional prophylactic

antimicrobial agent doses after the surgical incision is closed in the operating room.(Category IA)





1999 Guideline “…until, at most, a few hours after the incision is closed in the

operating room.” (Category IA)


≤48h for cardiac procedures


<24h for most procedures


<24h for all patients



Clinical Practice



Evidence Summary

All surgical Procedures: None vs. ≤24h

None = no additional doses after closing skin incision in the OR

≤24h = AFTER SKIN CLOSURE in OR

• Not including preoperative single dose or intraoperative redosing

High-quality evidence suggested no benefit of continuing AMP after closing the

skin incision in the OR:

Meta-analysis 19 RCT (N>11,000)

OR 1.29 (95%CI, 0.96-1.73); p=0.09





Evidence Summary

Specialty Study

Level

Comparator SSI*

Cardiac Tamayo 2008

Conte 1972

Austin 1980

1RCT

Moderate

None vs. ≤24h (N=838)

30/419 (7.2%) vs. 15/419 (3.6%); p=0.02

Superficial SSI: p=0.04

MRSA: 4/35 (11%) vs.9/15(60%); p=0.001 Excluded 5 deep SSI from analysis- study double counted between 1-3

3 RCT

Moderate

None vs. 72-96h Sternal O/S (2 RCT:N=908)

Superficial (3 RCT: N=992)

Sternal O/S: OR 0.44; 95% CI: 0.05 – 3.99; p=0.46

Sternal superficial:OR1.23; 95% CI: 0.44 – 3.44; p=0.69

Thoracic Bernard 1994

1RCT

Low

None vs. 2d (N=203)

Empyema: 6/102 (6%) vs. 1/101 (1%); p=0.03

Incisional: 7/102 (7%) vs. 2/101 (2%) P=0.11

Vascular Oostvogel 1987

Hall 1998

Hasselgren 1984

1 RCT

Moderate

None vs. <24h (N=169)

2/89 (3.8%) vs. 3/80 (2.3%), p>0.05

1 RCT

Moderate

<24h vs. 3d (N=121)

2/53 (3.8%) vs. (3/69) 4.3%; p=0.89

1 RCT

Moderate

None vs.5d (N=302)

28/153(18%) vs. 15/149(10%);

OR: 2.00; 95% CI: 1.02 – 3.92; p=0.04





Evidence Summary

Specialty Study

Level

Comparator SSI*

ENT Carroll 2003

Liu 2008

2 RCT

Moderate

≤24h vs. 3-5d (N=127)

OR: 1.54 (95% CI: 0.59 – 4.05); p=0.38

GYN Hemsell 1984

Turano 1992

Mayer 1993

Su 2005

4 RCT

Low

None vs. ≤24h (N=1317)

OR: 1.25; 95% CI: 0.50 – 3.13; p=0.63

1 RCT

Low

<24h vs. <2.5d (N=156)

2/74(2.7%) vs. 3/82(3.6%)

Ortho-Fracture Gatell 1987

Buckley 1991

Ali 2006

4 RCT

Low

None vs. ≤24h (N=1722)

OR: 1.71; 95% CI: 0.59 – 4.89; p=0.32

Ortho-

Arthroplasty Ritter 1989

Wymenga1992

2 RCT

Low

None vs. ≤24h (N=2847)

OR: 1.84; 95% CI: 0.68 – 4.98; p=0.23





Evidence Summary

Specialty Study

Level

Comparator SSI*

Colorectal Bowel preparation and

Oral antibiotics preop

Suzuki 2011

Becker 1991

1 RCT

Moderate

None vs. 3d (N=360)

15/179 (8.4%) vs. 13/181(7.2%); p=0.67

1 RCT

Low

≤24h vs. 5d (N=40)

0/22 vs. 0/18

Colorectal

Bowel preparation only

Carr 1984

Grundman 1987

Kow 1995

Fujita 2007

Juul 1987

Mendel 1987

Hall 1989

4 RCT

Moderate

None vs. ≤24h (N=910)

4RCT OR 1.47; 95% CI: 0.77 – 2.84; p=0.25

O/S 2 RCT OR 0.73; 95% CI: 0.30 – 1.77; p=0.49

3 RCT

Low

None vs. <2-3d (N=531)

OR 1.35 (95% CI: 0.70 – 2.61); p=0.37

O/S 1/149 (1%) vs. 2/145 (1%)

Colorectal Bowel preparation NR

Bates 1992

Wymenga 1985

Moesgaard1992

Karran 1993

McArdle 1995

1 RCT

Moderate

None vs. ≤24h (N=224)

23/113(20.4%) vs. 17/111(15.3%); P>0.2

4 RCT

Moderate

≤24h vs. 3d (N=802)

4 RCT OR 1.13; 95% CI: 0.75 – 1.70; p=0.57

O/S 3 RCT OR 0.77; 95% CI: 0.37 – 1.63; p=0.50





Evidence Summary Specialty Study

Level

Comparator SSI*

Colorectal No bowel preparation

(Emergency cases)

Kow 1995

Hall 1989

1 RCT

Low

None vs. ≤24h (N=46)

6/46 (13.0%); 4/21 (19.0%) vs. 2/25 (8.0%); p=0.28

1 RCT

Low

None vs. <2 – 3d (N=38)

1/17(5.8%) vs. 4/21(20.0%); p=0.26

Appendectomy Bates 1992

Kow 1995

Mui 2005

Hall 1989

3 RCT

Moderate

None vs. ≤24h (N=662)

OR 0.79; 95% CI: 0.45 – 1.42; p=0.43

1 RCT

Low

None vs. 2d (N=246)

3/127 (2.3%) vs. 10/119 (8.4%); p<0.05

Rectal Aberg 1995

1 RCT

Low


2/19(10.5%) vs. 1/29(3.4%); p=0.35

Gastric Aberg 1995

Mohri 2007

1 RCT

Low


1/24 (4%) vs. 4/40 (10%); p=0.41

1 RCT

Moderate

None vs. 4d (N=486)

23/243 (9.5%) vs. 21/243(8.6%) p=NS

Hepatectomy Togo 2007

1 RCT

Moderate

2d vs. 5d (N=180)

4/89(4.5%) vs. 4/91(4.4%)

Q2. NON-PARENTERAL

ANTIMICROBIAL/ ANTISEPTIC

STRATEGIES

Q2. What are the most effective strategies for local, non-

parenteral AMP to reduce the risk of SSI?

Q2A. Irrigation- antimicrobial/antiseptic

Q2B. Topical agents- antimicrobial/antiseptic

Q2C. Antimicrobial coated sutures

Q2D. Antimicrobial dressings



Q2A.1 ANTISEPTIC IRRIGATION

Q2A.1 How safe and effective is antiseptic irrigation?

Evidence Summary

2A.1 Antiseptic Irrigation

Electrochemically activated solutions (ECAS)- EXCLUDED

“for moistening absorbent wound dressings and for debriding and cleaning acute

and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers,

diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions

and minor irritations of the skin”*

* FDA: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060113.pdf Accessed May 1, 2013




Evidence Summary

Agent Study

Level

Comparator SSI*

Irrigation

Antiseptics

3 RCT

Moderate Cheng 2005

Chang 2006

Sindelar 1985

Aqueous Iodophor vs.

Normal Saline

Clean Spine (Cheng 2005, Chang 2006)*

Deep 2 RCT (N=658); OR: 0.07; 95% CI: 0.01 – 0.58; p=0.01

Superficial 2 RCT (N=658) Only 1 superficial SSI in NS group

Boths studies by same surgeons

11/12 (83.3%) MRSA(+) SSI

Contaminated: 1 RCT Intraabdominal abscess (n=90)

1/44 vs. 3/46: p=NS

Dirty: 1 RCT Intraabdominal abscess (n=98)

0/36 vs. 6/42; p<0.05 Sindelar 1985)

Adverse outcomes:

1 RCT 1 wound dehiscence aqueous iodophor group; 1 RCTs serum

iodine levels elevated 24 hours; near normal by 72 hours; no other

complications noted 1 RCT no product related adverse events




Draft Recommendation



JUNE 2013 NEW

2A.1. Use of aqueous iodophor irrigation prior to wound closure is not

necessary for prevention of surgical site infection. (Category II)

Or

Dot not use aqueous iodophor irrigation prior to wound closure for

prevention of surgical site infection (Category IB)

Q2A.2 ANTIMICROBIAL IRRIGATION

Q2A.2 How safe and effective is antimicrobial irrigation?

Evidence Summary

Our search did not reveal data that evaluated the safety and effectiveness of

antimicrobial irrigation or the soaking of surgical implants (i.e., meshes,

neurosurgical ventricular shunts, etc.) and surgical site infection.



Q2A.2 How safe and effective is antimicrobial irrigation?




JUNE 2013 UPDATED

2A.2 No recommendation can be made regarding the safety and

effectiveness of intraoperative antimicrobial irrigation and surgical site

infection. (No recommendation/ unresolved issue)

2A.3. No recommendation can be made regarding the safety and

effectiveness of soaking prosthetic devices in antimicrobial or antiseptic

solutions prior to surgical implantation and surgical site infection. (No

recommendation/unresolved issue)

MARCH 2013: Further research is needed to evaluate the safety and effectiveness of

antimicrobial irrigation and of soaking prosthetic devices in antimicrobial or antiseptic solutions

prior to surgical implantation. (No recommendation/unresolved issue)

Q2B. TOPICAL ANTIMICROBIAL/

ANTISEPTIC AGENTS?

Q2B.1 How safe and effective are topical antimicrobials?

Evidence Summary

Agent Study

Level

Comparator SSI*

Topical

Antimicrobials

1 SR

High

Ampicillin vs.

No topical antimicrobial

Meta 4 RCT (N=699)

OR 0.93; 95% CI: 0.27 – 1.72; p=0.90

1 RCT

Moderate

Chloramphenicol vs.


(N=92) 4/47 (8.5%) vs. 8/45 (17.8%); p=0.20

1 RCT

Low

Rifampin vs.


(N=48) reduced risk of umbilical port site infection

defined as purulent wound leakage (p<0.005)



Q2B.1 How safe and effective are topical antimicrobials?




JUNE 2013 UPDATED

2B.1. Do not use topical antimicrobial agents (i.e., ointments, solutions,

powders) prior to or following wound closure for prevention of surgical

site infection. (Category 1A)

MARCH 2013: Do not use topical antimicrobial agents (i.e., ointments, solutions) prior to or

following wound closure for prevention of surgical site infection. (Category 1A)

Q2B.2. How safe and effective are topical antiseptics?

Evidence Summary

Agent Study

Level

Comparator SSI*

Topical

Antiseptics

1 RCT

Low

Aqueous Iodophor to

skin prior to wound

closure vs. None

(N=107) 13/54 (24.1%) vs. 12/53 (22.6%); p=NS

1 RCT

Moderate

Iodophor powder

spray vs. Normal

saline

(N=200) 13/95 (13.7%) vs. 14/105 (13.3%); p=NS



Q2B.2. How safe and effective are topical antiseptics?




JUNE 2013 UPDATED

2B.2. Do not use additional topical antiseptic agents (i.e., ointments,

solutions, powders) after performing antiseptic skin preparation and prior

to wound closure for prevention of surgical site infection. (Category IB)

MARCH 2013: Use of topical skin antiseptic agents after performing skin preparation prior to

wound closure is not recommended for the prevention of surgical site infection. (Category II)

Q2B.3 How safe and effective is APRP?

Evidence Summary

Agent Study

Level

Comparator SSI*

Autologous

Platelet Rich

Plasma-APRP

3 RCT

Moderate

APRP vs. None (N=257) OR: 0.94; 95% CI: 0.42 – 2.13; p=0.89

Overall GRADE of evidence reduced from HIGH to MODERATE



Q2B.3 How safe and effective is APRP?




MARCH and JUNE 2013

2B.3 Do not use autologous platelet rich plasma for prevention of

surgical site infection. (Category IA)

Q2C. ANTIMICROBIAL SUTURES

Q2C. How safe and effective are topical antimicrobial

sutures and when and how should they be used?

Evidence Summary

Agent Study

Level

Comparator SSI*

Antimicrobial

coated sutures

4 RCT

High

Antimicrobial coated

vs.

Non-antimicrobial

(N=424) OR: 0.58; 95% CI: 0.18 – 1.90; p=0.37



Q2C. How safe and effective are topical antimicrobial

sutures and when and how should they be used?




MARCH and JUNE 2013

2C. Do not use antimicrobial coated sutures for the prevention of

surgical site infection. (Category IA)

Q2D. ANTIMICROBIAL DRESSINGS

Q2D. How safe and effective are antimicrobial

dressings? Evidence Summary/Draft Recommendation


antimicrobial dressings applied in the operating room following primary wound

closure.

JUNE 2013 UPDATE

2D. No recommendation can be made regarding the safety and

effectiveness of antimicrobial dressings applied to surgical wounds

following primary closure in the operating room.

(No recommendation/unresolved issue)

MARCH 2013 Further research is needed to evaluate the safety and effectiveness of antimicrobial

dressings.(No recommendation/unresolved issue)



Q3. GLYCEMIC CONTROL

Q3A. In diabetics and non-diabetics, how is the risk of

SSI impacted by blood glucose levels and what are the

optimal targets? Evidence Summary



Study

Level

Comparator SSI*

2 RCT

Moderate

Strict vs.

Standard

Glycemic control

1 RCT(N=371) 80-100mg/dL vs. <200mg/dL) (Ghandi 2007)

Composite outcome variable which included SSI:

82/185 vs. 86/186 RR 1.00 (95% CI, 0.8-1.2); p=0.71

Adjusted OR 0.09 (95% CI, 0.6-1.4); p=0.68

Deep sternal SSIs:

6/185 vs. 7/186 RR 0.90 (95%CI, 0.3-2.5); p=0.79

Hypoglycemia <60mg/dL “number of episodes in each group”

SICU: no difference number of episodes between groups (more episodes

intraoperatively as compared to in SICU)

1 RCT (N=109) 80-130mg/dL vs. 160-200mg/dL (Chan 2009)

Composite outcome variable which included SSI:

19.2% vs. 35.3%; p=0.12

SSI: 11.1% vs. 16.7%; p=0.09.

Hypoglycemia <50mg/dL; “ratio of hypoglycemic episodes per number of

glucose measurements”.

No difference between groups 2.9% vs. 2.1%, (95& CI, 0.84-1.43); P=0.67



optimal targets? Draft Recommendations

JUNE 2013 UPDATE

3A. Implement perioperative glycemic control and use blood glucose target

levels <200mg/dL in diabetic and non-diabetic surgical patients. (Category IA)

3A.1. No recommendation can be made regarding the safety and effectiveness

of lower or narrower blood glucose target levels and surgical site infection in

specific patient populations and postoperative settings.


MARCH 2013:

3. Implement perioperative glycemic control and use blood glucose target levels <180mg/dL in diabetic and non-diabetic

surgical patients. (Category IB)

3A.1. Further research to define optimal blood glucose target levels in diabetic, non-diabetic, and critically-ill surgical

patients should evaluate the benefits and harms associated with glycemic control in different surgical populations, and

postoperative settings which may impact choice of optimal target levels, delivery methods, timing of instituting, and

duration of the protocol. (No recommendation/unresolved issue)





optimal targets?

Clinical Practice 1999 Guideline Adequately control serum blood glucose levels in all diabetic patients and

particularly avoid hyperglycemia perioperatively. Category IB

2008 NICE Do not give insulin routinely to patients who do not have diabetes to optimize

blood glucose postoperatively as a means of reducing SSI

2009 Society for Thoracic Surgeons <180mg/dL diabetics, non-diabetics; non-critical

2011 American College of Chest Physicians 140-200mg/dL if insulin therapy in ICU

2012 Society for Critical Care Medicine <180mg/dL (>150 triggers intervention);critical



Q3B. In diabetics and non-diabetics, how is the risk of

SSI impacted by hemoglobin A1C levels?

Evidence Summary/Draft Recommendation

Our search did not reveal data that evaluated hemoglobin A1C levels and surgical

site infection.

JUNE 2013 UPDATED

3B. No recommendation can be made regarding hemoglobin A1C levels

and surgical site infection in diabetic and non-diabetic patients.


MARCH 2013: Further research is needed to understand the association between hemoglobin AIC

and the risk of surgical site infection in diabetic and non-diabetic patients.




KQ4-5. NORMOTHERMIA

Q4 How effective is maintenance of normothermia in

reducing the risk of SSI?

Evidence Summary



Study

Level

Comparator SSI*

2 RCT

High

Warming vs.

No warming

Meta 2 RCT (N=616) OR: 0.29; 95% CI: 0.16 – 0.53; p<0.0001

Mixed surgical populations, multiple warming techniques

1 RCT (N=416) 13/277 (5%) vs. 19/139 (14%); p=0.001 (Melling 2001)

Elective hernia repair, varicose vein and breast surgery

Preoperative systemic warming only

1 RCT (N=200) 6/104 (6%) vs. 18/96 (19%); p=0.009 (Kurtz 1996)

elective colorectal surgery patients using intraoperatively only warming:

1 RCT

Moderate

Perioperative vs.

Intraoperative only warming

1 RCT (N=103) 6/47(12.8%) vs.15/56 (26.8%) (Wong 2007)

OR 0.4 (95% CI, 0.14-1.13); p=0.08

Perioperative warming associated with lower blood loss (p=0.011)

Q4 How effective is maintenance of normothermia in

reducing the risk of SSI?


MARCH and JUNE 2013

4. Maintain perioperative normothermia (Category 1A)

Clinical Practice

2008 NICE Maintain patient temperature between 36.5º-37.5º

2009 Forbes perform active measures for prevention of hypothermia to reduce risk of SSI

2010 Hooper (ASPAN) recommendations for perioperative management

NICE website : http://www.nice.org.uk/cg74fullguideline Accessed 07 May 2013

Forbes S et.al. J Am Coll Surg. 2009 Oct;209(4):492-503.e1.

Hooper VD et al. J Perianesth Nurs. 2010 Dec;25(6):346-65



Q5. What are the most effective strategies for achieving

and maintaining normothermia?


JUNE 2013 UPDATED

5. No recommendation can be made regarding the safety and effectiveness

of strategies to achieve and maintain normothermia, determining the lower

limit of normothermia, optimal timing and duration, and surgical site

infection. (No recommendation/unresolved issue)

MARCH 2013: Further research is needed on the most effective strategies for achieving and maintaining

normothermia, particularly with respect to determining the lower limit, optimal timing, and duration. These studies

should all include SSI as an outcome. (No recommendation/unresolved issue)

Clinical Practice Guidelines 2009 Forbes S et.al. Evidence-based guidelines for prevention of perioperative hypothermia.

2010 Hooper VD et al. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative

normothermia

Forbes S et.al. J Am Coll Surg. 2009 Oct;209(4):492-503.e1.

Hooper VD et al. J Perianesth Nurs. 2010 Dec;25(6):346-65



Q6-7. OXYGENATION

Q6. In patients with normal pulmonary function, how safe and

effective is the perioperative use of increased FiO2/inspired oxygen

in reducing the risk of SSI, and when is it indicated?

Evidence Summary



Study

Level

Comparator SSI*

5 RCT

Moderate

80% oxygen vs.

30% oxygen No nitrous oxide -NO2

General anesthesia

Intraoperative intubation

3 RCT (N=1010) colorectal (n=800) and open appendectomy (n=210)

Each reported a 40% reduction in SSI with 80% oxygen.

Each optimized perioperative tissue oxygen delivery by standardizing

patient core temperature regulation strategies targeted at maintenance of

normothermia and fluid replacement to avoid hypo or hypervolemia (Belda. Bickle. Grief)

1 RCT (N=1,400) variety of general and gynecologic surgical procedures

No difference

Study did not optimize tissue oxygen delivery: failed to maintain

normothermia and instituted aggressive perioperative fluid restriction.

(Meyhoff, Staehr)

1 RCT

Low

80% oxygen vs.

35% oxygen NO2 30 min after induction

General anesthesia

Intraoperative intubation

1RCT interim analysis (n=160) (Pryor)

OR: 2.63; 95% CI: 1.1 – 6.2; p=0.02; RR: 2.22 (95% CI, 1.1-4.6)

Deep SSI: No difference; p=0.62

Wound infection: No difference; p=0.08

Both Deep and wound: No difference; p=1.0

Maintenance of normothermia and volume replacement not standardized




Evidence Summary



Study

Level

Comparator SSI*

1 RCT

Moderate

80% oxygen vs.

30% oxygen Neuraxial anesthesia

Intraoperative and postoperative

non-rebreathing mask

1 RCT (N=143) interim analysisin cesarean section (Gardella)

25% (95% CI, 15-35%) vs. 14% (95% CI, 6-22%); p=0.13.

2 RCT

High

28% -30% vs.

Room Air Face mask or nasal cannula

Postoperative only

1 RCT (N=274) lower limb vascular surgery (Turtiainen) ,

Multivariate analysis suggested no difference

18% vs. 28%; OR: 0.56; 95% CI: 0.30 – 1.04; p = 0.07

Isolated groin incision SSIs significantly lower in 30% oxygen group

5.8% vs. 23.5%; OR:0.20; 95% CI, 0.04-0.95;p=0.04

1 RCT(N=24) cervical spine surgery

No infections reported





MARCH AND JUNE 2013

6. In patients undergoing surgery with general anesthesia using mechanical

ventilation, administer increased fraction of inspired oxygen (FiO2)

intraoperatively and post-extubation in the immediate postoperative period,

in combination with strategies to optimize tissue oxygen delivery through

maintenance of perioperative normothermia and adequate volume

replacement. (Category IA)







JUNE 2013 UPDATED

6A. No recommendation can be made regarding the safety and

effectiveness of perioperative increased fraction of inspired oxygen (FIO2)

delivery and surgical site infection in patients undergoing surgery using

general anesthesia without mechanical ventilation, or neuraxial anesthesia

(e.g., spinal, epidural, or local nerve blocks).(No recommendation/

unresolved issue)

MARCH 2013 Further research is needed to understand the association between perioperative

increased fraction of inspired oxygen (FiO2) delivery and the risk of surgical site infection in patients

undergoing surgery with general anesthesia without mechanical ventilation or neuraxial anesthesia

(e.g., spinal, epidural or local nerve blocks). (No recommendation/unresolved issue)








1999 Guideline: No recommendation to provide measures that enhance wound space

oxygenation to prevent SSI. (Unresolved issue)

2008 NICE “Patient Homeostasis” Maintain optimal oxygenation…sufficient oxygen during

major surgery and in the recovery period to ensure that a haemoglobin saturation of more

than 95% is maintained. Maintain adequate perfusion and temperature during surgery



Q7.What is the optimal concentration of FiO2/inspired

oxygen, how and when should it be administered?


JUNE 2013 UPDATED

7. No recommendation can be made regarding optimal fraction of inspired

oxygen (FiO2) level, timing, duration, delivery method, and surgical site

infection. (No recommendation/unresolved issue)

MARCH 2013 Further research addressing the optimal fraction of inspired oxygen (FiO2), timing,

duration, and delivery method in surgical site infection prevention should also evaluate potential

benefits and harms. (No recommendation/ unresolved issue)



Q8. SKIN PREPARATION

Q8. What are the most effective strategies for preparing

the patient’s skin prior to surgery?

Q8A. NEW Preoperative antiseptic bathing/showering

Q8B. Intraoperative skin preparation

• Vaginal in combination with abdominal skin preparation EXCLUDED

Q8C. Antimicrobial Sealants

Q8D. Plastic Adhesive Drapes



Q8A. PREOPERATIVE

BATHING/SHOWERING

Q8A. How safe and effective is preoperative antiseptic

bathing or showering?

Evidence Summary



Study

Level

Comparator SSI*

1 SR

High (Webster 2008)

4% CHG solution vs.

Placebo

Meta 4 RCT (N=7791): RR 0.91 (95%CI, 0.80-1.04)

Meta 2 RCT (N=6302): RR 0.95 (95%CI, 0.82-1.10) (high quality)

No difference in each individual study

1 SR

High (Webster 2008)

4% CHG solution vs.

unmedicated bar soap

Meta 2 RCT (N=3589): RR 0.89 (95%CI, 0.36-2.19)

Heterogeneity High: P=0.08, I2 =60%

1 SR

Moderate (Webster 2008)

4% CHG solution vs.

No wash

Meta 3 RCT (N=1142) RR 0.82 (5% CI, 0.26-2.62)

1 SR

Moderate (Webster 2008)

4% CHG solution:

Whole body vs. partial

1 RCT (N=1093) 9/541 (1.7%) vs. 23/552 (4.1%);

RR 0.40 (95% CI, 0.19-0.85

1 RCT

Low (Veiga 2008)

10% aqueous iodophor

solution vs. “usual

personal hygiene”

No infections in either group at indeterminate follow up Study designed to assess impact of preoperative showering on skin

colonization, not SSI.

Q8A. How safe and effective is preoperative antiseptic

bathing or showering?


JUNE 2013 NEW

8A. Require patients to shower or bathe (full body-including scalp) on at

least the night before the operative day (Category IB)

8A.1. No recommendation can be made regarding the safety and

effectiveness of specific body cleansing products, the optimal timing or

number of product applications. (No recommendation/unresolved issue)


1999 Guideline Require patients to shower or bathe with an antiseptic agent on at least the night

before the operative day. Category IB

2008 NICE Advise patients to shower or have a bath (or help patients to shower, bath or bed bath)

using soap, either the day before, or on the day of, surgery.



Q8B. INTRAOPERATIVE

ANTISEPTIC SKIN PREP

Q8B. How safe and effective are topical antiseptic

products individually and in combination?

Evidence Summary



Study

Level

Comparator SSI*

2 RCT

Moderate

Aqueous Iodophor 1 step

vs.

Aqueous Iodophor 2 step

1 RCT (N=234) incisional:10% in each group

intra-abdominal (2% vs.3%; p=0.14) (Elllenhorn 2005)

1 RCT (N=108) Sternal SSI: 12% vs. 13% (Segal 2002)

5 RCT

Low

Aqueous Iodophor

vs.

Iodophor in alcohol

Meta 5 RCT (N=626) OR: 1.80 (95% CI: 0.50 – 6.52); p=0.37

NOTE: Overall GRADE reduced from HIGH to LOW Saltzman 2009, Segal 2002, Hort 2002, Roberts 1995, Gilliam 1990

5 RCT

High

CHG-alcohol

vs.

Aqueous Iodophor

Meta 5 RCT (N=1976)

OR: 0.59 (95% CI: 0.42 – 0.83); p=0.003 Sistla 2010, Darouiche 2010, Saltzman 2009, Paocharoen 2009), Bibbo 2005

5 RCT

Moderate

CHG-alcohol

vs.

Iodophor alcohol

Meta 5 RCT (N=1223)

OR: 0.64 (95% CI: 0.24 – 1.71); p=0.38

NOTE: Overall GRADE reduced from HIGH to MODERATE Cheng 2009, Saltzman 2009, Veiga 2008, Ostrander 2005, Berry 1982

Q8B. How safe and effective are topical antiseptic

products individually and in combination?


JUNE 2013 UPDATED

8B. Perform intraoperative skin preparation with an appropriate antiseptic

agent. (Category IA)

8B.1.a. Use chlorhexidine gluconate-alcohol in preference of aqueous

iodophor skin preparation, unless contraindicated. (Category IA)

8B.1.b. No recommendation can be made regarding the safety and

effectiveness of chlorhexidine gluconate-alcohol as compared to iodophor-

alcohol skin preparation.(No recommendation/unresolved issue)

MARCH 2013

Perform intraoperative skin preparation with an appropriate antiseptic agent.(Category IA)

Use an antiseptic agent with alcohol, unless contraindicated. (Category IA)



Q8C. ANTIMICROBIAL SEALANTS

Q8C. How safe and effective are antimicrobial sealants?

Evidence Summary/Draft Recommendation



Study

Level

Comparator SSI*

3 RCT

High (Silva von Eckardstein

2011, Iyer 2011,

Towfigh 2011)

Cyanoacrylate based

skin sealant vs.

No sealant

Meta-3 RCT (N=553) OR: 0.23; 95% CI: 0.04 – 1.22; p=0.08

3 RCT No significant product related sensitivity or other

adverse events Four episodes of some difficulty incising

through the film and visible flaking of the product in one

patient.

Q8C. How safe and effective are antimicrobial sealants?




MARCH and JUNE 2013

8C. Do not use antimicrobial skin sealant following skin preparation and prior

to skin incision for the prevention of surgical site infection.(Category IA)

Q8D. PLASTIC ADHESIVE DRAPES

Q8D. How safe and effective are plastic adhesive

drapes? Evidence Summary



Study

Level

Comparator SSI*

4 RCT

Moderate (Jackson 1971,

Psaila 1977,

Chiu 1993,

Ward 2001)

Non-iodophor drape

vs.

No drape

Meta 4 RCT (N=1742) RR: 1.05; 95% CI: 0.81 – 1.35; p=0.71

NOTE: Overall GRADE reduced from HIGH to MODERATE

2 RCT

High (Dewan 1987,

Segal 2002)

Iodophor drape

vs.

No drape

Meta 2 RCT (N=1113) RR: 1.03; 95% CI: 0.66 – 1.60; p=0.89

Q8D. How safe and effective are plastic adhesive

drapes? Draft Recommendations



MARCH and JUNE 2013

8D. Do no use plastic adhesive drapes (with or without antimicrobial

properties) for the sole purpose of preventing surgical site infection.

(Category IA)


2008 NICE

Do not use non-iodophor-impregnated incise drapes routinely for surgery as they may

increase the risk of surgical site infection.

If an incise drape is required, use an iodophor-impregnated drape unless the patient

has an iodine allergy.

DRAFT RECOMMENDATIONS

ARTHROPLATY SECTION

Q17. TRANSFUSION

Q17. TRANSFUSION

Q17. Blood transfusion and risk of SSI

Q17A. Specific blood products and risk of SSI

Q17B. Operative severity and risk of SSI

Q17C. Volume of transfused blood product and risk of SSI

Q17.D Safety and effectiveness of withholding transfusion



Q17 TRANSFUSION

2 RCTs and 7 OBS studies reflect European transfusion practices between 1999-2007

(4 not reported)

Hemoglobin thresholds for blood transfusion: 8 -11g/dL

2012 American Association of Blood Banks

• Strong recommendation for more restrictive transfusion strategies:

• Hemodynamically stable postoperative surgical patients

Hemoglobin ≤8g/dL or symptoms (e.g., chest pain, orthostatic hypotension or

tachycardia unresponsive to fluid resuscitation, or congestive heart failure).

• Adult and pediatric intensive care unit patients

Hemoglobin ≤7g/dL

Carson JL et.al. Clinical Transfusion Medicine Committee of the AABB. Red blood cell transfusion :a clinical practice guideline from the AABB*.Ann Intern Med. 2012

Jul 3;157(1):49-58.



Q17. TRANSFUSION

Q17. How is the risk of SSI impacted by perioperative

transfusion in arthroplasty patients?

Evidence Summary



Agent Study

Level

Comparator SSI*

ALLO, AUTO,

AUTO+ALLO

2 RCT

4 OBS

High

Transfusion vs.

No transfusion

Meta 6 studies (N=8493)

OR: 1.56; 95% CI: 1.18 – 2.06; p=0. 002

Meta 4 OBS (N=7484) (ALLO or AUTO+ALLO)

OR 1.59; 95% CI: 1.15 – 2.18; p=0.004 (Lewelyn 2004, Weber 2005, Innerhofer 2005, Rosencher 2003)

Meta 2 RCTs 2 RCT (N=1009)

OR 1.07; 95% CI: 0.39 – 2.89; p=0.90. (Frietsch 2001,2008)

Q17A. TRANSFUSION-

SPECIFIC BLOOD PRODUCTS

Q17A. Are specific blood products associated with

increased or decreased risk?

Evidence Summary – ALLOGENEIC BLOOD

Studies

GRADE

Comparator SSI SSI Risk

4 OBS

Low

ALLO vs.

No transfusion

Meta 4 OBS (N=5737)

OR: 1.96; 95% CI: 1.46 – 2.63; p<0.001 Increased with

ALLO

1 OBS

Low

Not WBC depleted-WBCD

vs.

No transfusion

(N=1644) 18/464 (4%) vs. 22/1180 (2%)

OR: 2.12; 95% CI: 1.13 – 4.00; p=0.02 Actual WBC content was not reported

Increased with

NOT WBCD

1 OBS

Very low

WBCD vs.

No transfusion (N=1817) 18/637 (3%) vs. 22/1180 (2%); p=0.19 Actual WBC content was not reported

No difference

1 OBS

Very low

Buffy coat depleted-BCD vs.

No transfusion (N=444) PJI: 1 % vs. 1 %; p=NS

Incisional SSI: 3.3% vs. 2.0%; p=0.47 WBC content: 0.4 X 109 WBC per liter

No difference

2 OBS

Low

WBC Filtered-WBCF vs.

No transfusion

Meta 2 OBS (N=1637)

OR: 1.92; 95% CI: 1.12 – 3.29; p=0.02 1 OBS (n=201) WBC content: 0.27 X 106 per unit- no difference

1 OBS (n=1436) WBC content: 5 X 106 per unit –increased risk

Increased with

WBCF*





Evidence Summary – AUTOLOGOUS BLOOD

Studies

GRADE


2 RCT

2 OBS

Moderate

AUTO vs.

No transfusion

Meta 2 RCT (N=970) OR: 1.15, 95% CI: 0.43 – 3.13; p=0.78

1 OBS (N=2491) 11/1311 (1%) vs. 22/1180 (2%);

OR: 0.45; 95% CI: 0.22 – 0.92; p=0.03

1 OBS (N=186) 0/85 vs.1/101 NOTE: GRADE reduced from HIGH to MODERATE

No difference

1 RCT

Low

Whole blood vs.

No transfusion

(N=34) no infections in either group Study evaluated transfusion induced immunomodulation, not SSI (7 day follow up)

Blood = AUTO donated and perioperative salvage

No difference

1 OBS

Very Low

Not WBCD vs.

No transfusion

(N=2491) OR: 0.45; 95% CI: 0.22 – 0.92; p=0.03 Donated WB/PRBC, cell saver, acute normovolemic hemodilution, postop salvage

Donated blood only:4/610 (0.66%) vs. 22/1180 (1.86%); p=0.053

Postoperative salvage only: 8/191 (4.19%) vs. 22/1180 (1.86%) p<0.05

No difference Increased with

postop

salvage only

1 RCT

1 OBS

Low

BCD vs.

No transfusion

1 RCT (N=33) no infections; WBC: 80-90% WBCs and >98% platelets depleted

Study evaluated transfusion induced immunomodulation, not SSI (7 day follow up)

1 OBS (N=186) 0/85 vs.1/101- too few events; WBC: 2-30KWBC/µL

No difference

1 RCT

Moderate

±WBCF vs.

No transfusion

(n=657) No WBCF 5/226(2.2%) vs. 7/431(1.6%); p=0.59

(n=686) WBCF: 3/255(1.2%) vs. 7/431(1.6%); p=0.64; WBC<1 X106 per unit

No difference





Evidence Summary – AUTOLOGOUS PLUS ALLOGENEIC

Studies

GRADE


1 RCT

2 OBS

Moderate

AUTO plus ALLO

vs. No transfusion

1 RCT (N=470) 0/39 vs. 7/ 431 (1.6%) p=0.82

1 OBS (N=1509) 8/329 (2%) vs. 22/1180(2%)

OR: 1.31; 95% CI: 0.58 – 2.97; p=0.52

1 OBS (n=123): 0/22 vs. 1/101 (1%); p=NS

No difference



Q17B. TRANSFUSION-

OPERATIVE SEVERITY

Q17B. If the risk is increased, can this effect be isolated

from the risk associated with operative severity?

Evidence Summary

Our search did not reveal data that directly evaluated the association between increasing

transfusion requirements, operative severity, and risk of SSI.

3 OBS stratified transfusion requirement by procedure type (Lewelyn, Borghi, Rosencher)

1 OBS reported blood loss by procedure type (Rosencher)

Critical outcome: Transfusion*



Q17B. If the risk is increased, can this effect be isolated

from the risk associated with operative severity?

Evidence Summary

Study

GRADE

Comparator Transfusion Risk Blood Transfusion Type

Risk

2 OBS

Moderate

Revision Hip & Knee

vs. Primary Hip & Knee

Meta 2 OBS (N=6385);

OR 3.81 (95% CI: 1.61 – 9.03); p=0.002

1 OBS

Very Low

Revision Hip vs.

Revision Knee

N=362;252/293 (86%) vs. 51/69 (74%);

p=0.02

No difference in median calculated blood loss

2 OBS

Low

Revision Hip vs.

Primary Hip

N=2359 ;252/293(86%) vs. 1405/2066(68%);

p<0.001

Higher mean calculated blood loss in revision

hips ; p=0.0003 (Meta 2 OBS)

Revision hip: ALLO; p=0.003

Revision hip: ALLO+AUTO; p<0.001

Primary hip: AUTO; p<0.001

1 OBS

Very Low

Revision Knee vs.

Primary Knee

N=1121; 51/69(74%) vs. 707/1052 (67%);

p=0.25

Bilateral: N=82; 51/69 (74%) vs. 11/13(85%);

p=0.42

Higher mean calculated blood loss in

revision knee ; p=0.002

Revision Knee: AUTO+ ALLO;

p=0.02



Q17C. TRANSFUSION- VOLUME

Q17C. How does volume of transfused blood product

impact this risk of SSI?

Evidence Summary

Our search did not reveal data that evaluated differences in volume of

transfused blood product and their impact on the risk of SSI in arthroplasty

procedures.



Q17D. TRANSFUSION-

WITHHOLDING

Q17.D How safe and effective is withholding transfusion

in decreasing the risk of SSI?

Evidence Summary


withholding transfusions and included SSI as an outcome in arthroplasty

procedures.

1999 Guideline

Do not withhold necessary blood products from surgical patients as a

means to prevent SSI. Category IB



Q17 TRANSFUSION SUMMARY

Q17. High quality evidence suggested transfusion increased the risk of SSI

Q17A. Low quality evidence suggested allogeneic blood increased the risk of SSI

Higher WBC content allogeneic blood

Moderate quality evidence suggested autologous or autologous plus

additional allogeneic blood did not increase the risk of SSI

Q17B. Moderate quality evidence suggested revision arthroplasties increased the

risk of transfusion.

Very low quality evidence suggestion effect limited to revision THA

Q17C. Search revealed no data on transfusion volume and SSI.

Q17D. Existing guidance recommends not withholding blood products to prevent SSI



Q17 TRANSFUSION QUESTIONS

1) Could the increased risk of SSI with transfusion and ALLO blood be a

surrogate for a wound that was already at risk prior to the transfusion by

function of an unexpected high blood loss, with associated decreased volume

and oxygen tension, and increased vasoconstriction?

2) Could AUTO be associated with no difference in risk because of a lower

threshold to transfuse the patient with his/her own blood, also smaller studies,

with fewer events?

3) Is this more a matter of having a multidisciplinary approach to blood

management? Preoperative optimization, better planning for anticipated blood

loss, AUTO candidates? Intraop cell saver/postop techniques,?



Q17 TRANSFUSION –


JUNE 2013 NEW

17. No recommendation can be made regarding blood transfusion products ,

their perioperative management and surgical site infection in patients

undergoing prosthetic joint arthroplasty procedures.




Q18-22. IMMUNOSUPPRESSIVE

THERAPY: SYSTEMIC AND

INTRA-ARTICULAR

Q18-20. Immunosuppressive therapy-

SYSTEMIC

Q18. Immunosuppressive therapy and risk of SSI

KQ18A. Length of time used preoperatively

KQ18B. Dose

Q19. Strategies for managing their perioperative use

KQ19A. Dose

KQ19B. Discontinuation

Q20. Optimal postoperative duration of AMP



Q18-20. Immunosuppressive Therapy- Systemic

Evidence Summary

Author Publication

Year

Study Dates Country

OBS Momohara 11035 2011 2005-2009 Japan

OBS Hirano 13944 2010 2004-2007 Japan

OBS Kawakami 11004 2010 2004-2009 Japan

OBS Bongartz 14006 2008 1996-2004 USA

OBS Carpenter 14767 1996 1982-1991 USA

OBS Bridges 14765 1996 1981-1989 USA

OBS Perhala 14766 1991 1978-1987 USA




SYSTEMIC

Disease Modifying Anti-Rheumatic

Drugs (DMARDs)

Biologic Agents Corticosteroids

Anti-Tumor

Necrosis

Factor (TNF)

Non-TNF

methotrexate

(MTX)

sulfasazaline infliximab anakinra prednisone

hydroxychloriquine azathioprine adalimumab abatacept

leflunomide cyclosporine etanercept rituximab

minocyclinem gold certolizumab

pegol

tocilizumab

golimumab




SYSTEMIC

All studies were in rheumatoid arthritis (RA) patients

“Established” disease >6 months

RA Treatment - progression from DMARD monotherapy, to DMARD

double or triple therapy, to use of biologic agents is indicative of

progression from low to high disease activity with or without poor

prognostic features

Patients on biologic agents can also be on combined DMARD and/or

corticosteroid therapy

Singh JA, et al., Arthritis Care Res (Hoboken). 2012 May;64(5):625-39.



Q18. IMMUNOSUPPRESSIVE

THERAPY: SYSTEMIC

AGENT AND SSI RISK

Q18. How is the risk of SSI impacted by the use of

systemic corticosteroids, or other immunosuppressive

agents in arthroplasty patients? Evidence Summary



Study

GRADE

Comparator SSI

2 OBS

Very low

Biologic agents vs.

DMARDs

Meta 2 OBS (N=528)

SSI: OR: 5.90; 95% CI: 2.68 – 12.99; p<0.0001 (Moderate)

Superficial: OR: 5.80; 95% CI: 2.55 – 13.18; p<0.0001 (Moderate)

PJI: OR: 3.59; 95% CI: 0.52 – 24.88; p=0.20) (Very Low) In each of these studies, multivariate logistic regression analysis identified biologic

agents as a significant risk factor SSI

1 OBS

Very Low

DMARD

Vs.

No therapy

1 OBS (N=202)

PJI: 3/92 (3.26%) vs. 2/110 (1.81%); p=0.66

Deep wound abscess: 0/92 vs. 1/110 (0.91%); p=0.57

Infected hematoma: 2/92 (2.2%) vs. 1/110 (0.9%); p=0.47 DMARD group: weekly low-dose pulse MTX within 4w of surgery

No therapy: never had MTX (some on prednisone- number NR)

Q18A. Does the length of time used preoperatively

affect the risk of SSI?

Evidence Summary



Study

GRADE

Comparator SSI

2 OBS

Low

Disease Duration Multivariate logistic regression analysis in 2 OBS studies suggested

disease duration was a risk factor for SSI:

1 OBS (N=420) OR 1.09; CI 1.04-1.14; p=0.003 (Momohara 2011)

1 OBS (N=108) OR 1.17: 95%CI, 1.03-1.33; p=0.015 (Kawakami 2010)

Q18B. Does the dose affect the risk of SSI?

Evidence Summary

Our search did not reveal data that evaluated differences in biologic agent or

DMARD doses and their impact on the risk of SSI in arthroplasty procedures.



Study

GRADE

Comparator Prednisone Dose (mg/day) and SSI

2 OBS

Very low

Prednisone dose

Biologics vs.

DMARDs

Conflicting results on logistic regression analysis in 2 OBS :

(N=128) OR 1.433 (95%CI, 1.007-2.040); p=0.046 (Kawakami 2010)

Patients on biologics were on higher doses of prednisone (5mg/day (range, 2-7)

as compared to patients on DMARDs Prednisone 3mg/day (range, 0-5);p=0.006

(N=420) OR 1.09 (95%CI, 0.93-1.28); p=0.27 (Momohara 2011)

Both patient groups were on Prednisone 3mg/day (range, 0-5);p=0.27

Q18 Immunosuppressive Therapy- Systemic

Risk Factors SUMMARY and Draft Recommendation

Q18. Very low quality evidence suggested biologic agents increased the risk of SSI.

Q18A. Low quality evidence suggested disease duration increased the risk of SSI.

Q18B. Very low quality evidence was indeterminate for systemic corticosteroid dose and its

impact on SSI. Our search did not identify studies that evaluated differences in biologic

agent or DMARD doses and their impact on the risk of SSI in arthroplasty patients.

Findings address non-modifiable risk factors; do not allow for a recommendation



Q19. WHAT ARE THE MOST EFFECTIVE

STRATEGIES FOR MANAGING THEIR

USE?

Q19A. Should dosing be adjusted, and if so, for how

long? Evidence Summary

Our search did not reveal data that evaluated perioperative systemic

corticosteroid and other immunosuppressive therapy dose adjustment and its

impact on the risk of surgical site infection in arthroplasty procedures.



Q19B. How safe and effective is discontinuation of

these agents preoperatively, and when should they be

resumed? Evidence Summary

• Methotrexate doses might be considered subtherapeutic in current clinical practice



Study

GRADE

Comparator SSI

4 OBS

Low

DMARD stopped vs.

Continued

Meta 3 OBS (N=180) (Carpenter 1996, Perhala 1991, Bridges 1996)

PJI: 1/105 (1%) vs. 6/75(8%); OR: 0.20; 95% CI: 0.04 – 1.03; p=0.05

1 OBS (N=462 patients; 657 procedures- 336 on DMARDs)

DMARD stopped in 192/336 (57%) of these procedures.

Stopping DMARDs: HR 0.65 (95% CI, 0.09-4.95); p=NS (Bongartz 2008)

1 OBS

Very Low

Biologic agents

stopped vs.

Continued

1 OBS (N=462 patients; 50 on biologic agent therapy

0/12(0%) vs. 3/38 (7.9%); p=NS (Bongartz 2008)

Biologic agents: etanercept, adalimumab, infliximab, or anakinra)





DMARDs- conflicting recommendations

2008 3 E Initiative- Methotrexate can be safely continued in the perioperative

period in rheumatoid arthritis patients undergoing elective orthopaedic surgery .

• Studies used to make that recommendation used weekly methotrexate doses from 4 to

13mg/week.

2008 American College of Rheumatology (ACR) offered no recommendation

regarding the use of DMARDs during the perioperative period due to the absence

of consistent evidence.

2012 American College of Rheumatology (ACR)- does not address the topic







Biologic agents- conflicting recommendations

2005 British Society for Rheumatology- treatment with infliximab, etanercept,

and adalimumab (anti-TNF) should be withheld for 2-4 weeks prior to major

surgery. Restart postoperatively if no evidence of infection and wound healing is

satisfactory.

• Based on information provided by the drug companies and no references were cited to

support them.

2008 American College of Rheumatology (ACR) biologic agents should not be

used during the perioperative period, for at least one week prior to and one week

after surgery, based on the pharmacokinetic properties of a given agent.

2012 American College of Rheumatology (ACR)- does not address the topic



Q19. Immunosuppressive therapy- Systemic:

Strategies for managing their use perioperatively


JUNE 2013 NEW

19. No recommendation can be made regarding the perioperative

management of systemic corticosteroid or other immunosuppressive therapy,

including dosing, discontinuation, and surgical site infection in patients

undergoing prosthetic joint arthroplasty procedures.




Q20B. DURATION OF AMP

IN PATIENTS ON

IMMUNOSUPPRESSIVE THERAPY

Q20. What is the optimal duration of AMP for reducing

the risk of SSI in patients on corticosteroids or other

immunosuppressive agents? Evidence Summary

Our search did not reveal data that evaluated differences in antimicrobial

prophylaxis duration in arthroplasty patients using systemic corticosteroids or

other immunosuppressive agents and their impact on the risk of SSI.



Q20 Immunosuppressive Therapy- Systemic

Postoperative AMP Duration


JUNE 2013 NEW

20. No recommendation can be made regarding the safety and

effectiveness of postoperative antimicrobial prophylactic agent duration

in prosthetic joint arthroplasty patients on systemic immunosuppressive

therapy and surgical site infection.


Carson JL et.al. Clinical Transfusion Medicine Committee of the AABB. Red blood cell transfusion :a clinical practice guideline from the AABB*.Ann Intern Med. 2012

Jul 3;157(1):49-58.



Q21-22.

INTRA-ARTICULAR

CORTICOSTEROIDS


INTRA-ARTICULAR CORTICOSTEROIDS

Q21. Intra-articular corticosteroid injection and risk of SSI

Q21A. Length of time used preoperatively and risk of SSI

Q21B. Dose and risk of SSI

Q22. Strategies for managing their use



Q21. How is the risk of SSI impacted by the use of

preoperative intra-articular corticosteroids in

arthroplasty patients? Evidence Summary



Study

GRADE

Comparator SSI

5 OBS

Low

Injection vs.

No injection

Meta 5 OBS (N=1146) 35/476 (7.4%) vs. 26/670 (3.9%)

OR: 1.91; 95% CI: 1.01 – 3.61; p=0.05

2 OBS

Very Low

TKA: Injection vs.

No injection

Meta 2 OBS (N=414) (Papvasiliou 2006, Desai 2009)

PJI: 3/144 vs. 0/270; OR: 12.30; 95% CI: 0.62 – 242.88; p=0.10

Superficial: 14/144 vs. 15/270; OR: 1.71; 95% CI: 0.68 – 4.31; p=0.26

3 OBS

Very low

THA: Injection vs.

No injection

Meta 3 OBS (N=732) (Sreekumar 2007, McIntosh 2006, Kaspar 2005)

PJI: 7/332 vs. 2/400; OR: 2.95; 95% CI: 0.61 – 14.18; p=0.18

Superficial: 11/332 vs. 9/400; OR: 1.32; 95% CI: 0.54 – 3.22; p=0.55

Q21A. Does the length of time used preoperatively affect

the risk of SSI? Evidence Summary

Our search did not reveal data evaluating length of corticosteroid injection use and risk

of SSI in TKA.



Study

GRADE

Comparator Length of time between most recent injection and

surgery and SSI risk

1 OBS

Very Low

Infection and/or

infection tests vs.

No infection

and/or infection

tests

(N=80) matched, cohort (injected: not injected) study found that neither:

the total number of injections (p=0.891) before THA nor

the time interval between the injection and the operation (p=0.878) differed.

Study underpowered for these measures (0.052 and 0.053, respectively) (Kaspar)

1 OBS

Very Low

PJI vs.

Superficial SSI

(N=448) No association between the average time from intra-articular

corticosteroid injection to primary THA and the development of PJI or

superficial SSI. (McIntosh)

Meant time between injection and THA for 3 patients who developed PJI

was less than half the length of time for those who developed superficial

SSI (n=11): 44 days (SD=23) vs. 112days (SD=94d).

Q21B. Does the dosage affect the risk of SSI? Evidence

Summary

Our search did not reveal data that evaluated the impact of injection with

different doses of corticosteroid injections on risk of SSI in arthroplasty

procedures.

Agent and doses varied between the studies:



Author Agent Country

TKA

2 OBS Desai 2009 methylprednisolone 40mg/dL and

levobupivacaine 5mg/ml

UK

Papavasiliou 2006 methylprednisolole UK

THA

3 OBS Sreekumar 2007 methylprednisolone 40mg/dL and

levobupivacaine 5mg/ml

UK

McIntosh 2006 Not standardized USA

Kaspar 2005 methylprednisolone 80mg with 1-5ml

bupivacane

Canada

Q21 Immunosuppressive Therapy-

Intra-articular corticosteroid injection Risk of SSI:


JUNE 2013 NEW


effectiveness of intra-articular corticosteroid injection agent, dose, or

the length of time since administration prior to prosthetic joint

arthroplasty procedures and surgical site infection.




Q22. What are the most effective strategies for

managing the use of intra-articular corticosteroids?

Evidence Summary

Our research did not reveal data that evaluated strategies for managing the use

of intra-articular corticosteroids and their impact on risk of SSI in arthroplasty

procedures.

2012 American College of Rheumatology practice guidelines include intra-

articular corticosteroid injections among their pharmacologic recommendations

(“not strong”) for the initial management of knee and hip osteoarthritis but do

not provide information on management strategies.

Hochberg MC, et al., Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74



Q22 Immunosuppressive Therapy-

Intra-articular corticosteroid injection perioperative

management: Draft Recommendation

JUNE 2013 NEW

22. No recommendation can be made regarding perioperative

management of intra-articular corticosteroid injections, agent, dose,

discontinuation, and surgical site infection in patients prior to prosthetic

joint arthroplasty procedures.




Q23. ANTICOAGULATION

Q23. ANTICOAGULATION

Q23 Perioperative anticoagulation for venous thromboembolism

(VTE) prophylaxis and risk of SSI

Q23A Risk by VTE prophylaxis agent

Q23B Optimal timing and duration to reduce the risk SSI

Q23C How safety and effectiveness of altering VTE prophylaxis



Q23A. Does SSI risk differ by VTE prophylaxis

agent? Evidence Summary

Anticoagulants Antiplatelet

Factor Xa & IIa Indirect

Factor Xa

Direct

Factor Xa

Vitamin K

(II, VII, IX, X)

COX

Inhibitor

Agent UFH 20KD

heparin

LMWH 3KD

enoxaparin

fondaparinux rivaroxaban warfarin aspirin

Date 1916 1990’s 2001 2011 1950’s 1897

Delivery IV or SC

Injection

SC

Injection

SC

Injection

Oral Oral Oral

Onset IV:Immediate;

SC:

20-60min

3-5h 1-3h 30min 36-72h 15-30min

Duration IV: 2-6h

SC:8-12h

12h 24h 24h 48-96h 4-8h

Half-life 1h 4.5h 17-21h 5-9h young

11-13h older

20-60h 15-20min

Reversal Protamine Protamine NONE NONE Vitamin K NONE



Q23A Does SSI risk differ by VTE prophylaxis

agent? Evidence Summary

11 studies: low molecular weight heparin (LMWH) vs. another agent

3 studies: warfarin vs. aspirin (ASA) ± mechanical or no prophylaxis

SSI not the primary outcome of interest in the majority of studies

None of the studies evaluated

• LMWH vs. warfarin

• clopidogrel

• unfractionated heparin

Agent dose, timing of administration, duration of VTE prophylaxis,

concomitant use of aspirin or mechanical prophylaxis, and follow up

varied between studies



Q23B What is the optimal timing and duration of perioperative VTE

prophylaxis to reduce the risk of SSI?

Evidence Summary

Risk of deep venous thrombosis, bleeding and hematoma formation addressed by

multiple other anticoagulation prophylaxis and treatment guidelines- our literature

search focused on SSI.

2012 VTE Prophylaxis in Ortho: “Bleeding leading to infection”

• No RCTs or controlled OBS studies evaluated the impact of the following

comparators on this outcome:

Pharmacologic prophylaxis vs. no prophylaxis

Comparisons between pharmacologic and/or mechanical classes of prophylaxis

Comparative efficiency between individual LMWH agents

Comparative efficiency between individual mechanical prophylaxis device

Impact of combined pharmacologic and mechanical prophylaxis vs. single modality

Effect of prolonging prophylaxis for 28d or longer vs. 7-10d

Venous Thromboembolism prophylaxis in orthopaedic surgery. Comparative Effectiveness Review No.49. AHRQ Publication No. 12-EHC020-EF:

http://effectivehealthcare.ahrq.gov/ehc/products/186/992/CER-49_VTE_20120313.pdf

Q23A. Does SSI risk differ by agent?

Evidence Summary

Low molecular weight heparin (LMWH)

Study

GRADE

Comparator SSI

1 SR

Low

enoxaparin vs.

fondaparinux

Meta 4 RCT (N=7237) 29/3621 (0.8%) vs. 37/3616 (1.0%); p=NS Primary & revision THA, TKA, hip fracture surgery (11d f/u)

4RCTs

High

enoxaparin vs.

rivaroxaban

Meta 4 RCT (N=12,383) 28/6200 (0.5%) vs. 27/6183 (0.4%)

OR: 1.03; 95% CI: 0.60 – 1.76; p=0.92 Primary/revisionTHA (2mo f/u) and TKA (6w f/u)

1 OBS

Very low

enoxaparin vs.

ASA + mechanical

1 OBS (N=2437) Logistic regression analysis

Primary THA OR 2.11 (95%CI, 0.24-18.5); p=0.499

Primary TKA OR 1.07 (95% CI, 0.23-4.95); p=0.932

1 OBS

Very low

enoxaparin vs. bemiparin vs.

fraxiparin vs. fondaparinux

1 OBS (N=150) No increased risk: p=0.97

TKA nested case-control study (44:106)

1 OBS

Very low

enoxaparin, dalteraparin or

tinzaparin OR fondaparinux vs.

ASA ± mechanical

1 OBS (N=41,917) 4366/37,198 (12%) vs. 559/4719 (12%); p=NS



Q23A. Does SSI risk differ by agent?

Evidence Summary

Warfarin

Study

GRADE

Comparator SSI

1 OBS

Very low

Warfarin

vs.

no pharmacologic or mechanical

prophylaxis

1 OBS (N=1742) primary unilateral TKA (f/u 3mo)

SSI rare (0.8%) and did not differ between groups. Target INR: 1.6-2.2 for 6 weeks

2 OBS

Low

Warfarin

vs.

aspirin ±mechanical prophylaxis

1 OBS (n=2437) primary THA/TKA (f/u NR) Target INR=2.0

Logistic regression analysis: no increased risk of SSI

1OBS (n=56,642) primary TKA Target INR not reported.

subanalysis: no difference- Adjusted OR: 1.10 (95%CI, 0.96-1.26).

SSIs detected on admission/readmission within 30d

1 OBS

Very Low

Warfarin

Higher vs. Lower Mean INR

1 OBS (N=234) 2:1 infected: not infected; THA/TKA Target INR=1.5

Mean INR higher in the infected but (p=0.06)

Mean INR higher in patients with wound-related problems who later

developed infection (p=0.03)



Q23B. What is the optimal timing and duration of perioperative

anticoagulation prophylaxis to reduce the risk of SSI?

Evidence Summary

Our search did not reveal data that directly evaluated

optimal timing of perioperative VTE prophylaxis with oral agents or in THA and SSI.

optimal duration of perioperative VTE prophylaxis and SSI.



Study

GRADE

Comparator SSI

1 OBS

Very Low

VTE prophylaxis started

Within 12h or >12h

Preoperatively vs.

Postoperatively

1 OBS nested case-control study (n=36 infections, 106 controls) TKAs

Infected patients received the first dose of injectable VTE prophylaxis

within 12h (before or after) of surgery more frequently than those not

infected: OR 1.5; (95%CI, 0.73-3.0). (Asension 2010)

After adjusting by main risk factors, no statistical association was found

between close perioperative timing of the first dose of anticoagulant and

risk of PJI.

Hematoma formation-independent risk factor for PJI.

Adjusted OR 4.2; 95%CI, 1.1-16.6

Q23B What is the optimal timing and duration of perioperative VTE

prophylaxis to reduce the risk of SSI?

Evidence Summary


2012 American Academy of Orthopaedic Surgeons

2012 American College of Chest Physicians

Focused on prevention of VTE in patients undergoing THA, TKA, or hip

fracture surgery and provide recommendations on agent choice, timing,

and duration.

Falck-Ytter Y, et.al., American College of Chest Physicians. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis,

9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e278S-325s.

Jacobs JJ, et.al., American Academy of Orthopaedic Surgeons clinical practice guideline on: preventing venous thromboembolic disease in patients undergoing

elective hip and knee arthroplasty. J Bone Joint Surg Am. 2012 Apr 18;94(8):746-7.

The findings and conclusions are draft and have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to

represent any agency determination or policy.

Q23C How safe and effective is altering VTE

prophylaxis perioperatively?

Evidence Summary


altering VTE prophylaxis perioperatively and surgical site infection in arthroplasty

procedures.

JUNE 2013 NEW


management of VTE prophylaxis agent, dose, discontinuation, and

surgical site infection in prosthetic joint arthroplasty procedures.

(No recommendation/ unresolved issue)



Q23 Anticoagulation


JUNE 2013 NEW


management of VTE prophylaxis agent, dose, discontinuation, and

surgical site infection in prosthetic joint arthroplasty procedures.




Q26. ORTHOPAEDIC

EXHAUST SUIT

Q26. How safe and effective is an orthopaedic exhaust

suit for reducing the risk of SSI in arthroplasty patients?

Q26A. Who should wear them? Evidence Summary



Study

GRADE

Comparator SSI

3 OBS

Very Low

Exhaust Suit vs.

No Exhaust Suit

Deep SSI requiring reoperation (Miner)

1 OBS (N=8288) in TKA using Medicare claims data (90day)

0.28% (95%CI 0.11-0.46) vs. 0.38% (95%CI 0.20-0.55);

RR 0.75 (95% CI, 0.34-1.62)

Use of laminar flow varied Deep SSI could be PJI

Deep SSI requiring revision (Hooper)

1 OBS (N=88,311) national joint registry; multiple subgroup analyses

Use of exhaust suits was associated with an increased number of deep SSIs

requiring revision surgery within 6 months of THA or TKA (P<0.001)

Evidence limited in size (only 96 events or 0.109%):

Results did not differ in the presence or absence of laminar flow

60% of primary procedures used antimicrobial impregnated cement. Deep SSI could be PJI

Deep SSI (Pasquarella)

1 OBS (N=62) evaluating contamination using body exhaust or conventional

gowns during THA or hip hemiarthroplasty

1/31 (3.2%) vs. 0/31. (24 month follow up).

HEPA filtration was present in both study groups. Deep SSI was not defined

Q26. How safe and effective is an orthopaedic exhaust

suit for reducing the risk of SSI in arthroplasty patients?

Q26A. Who should wear them? Draft Recommendation

JUNE 2013 UPDATE


effectiveness of orthopaedic exhaust suits, the health care personnel that

should wear them and surgical site infection in prosthetic joint arthroplasty

procedures. (No recommendation/unresolved issue)

MARCH 2013: Further research addressing the use of orthopaedic exhaust suits and SSIs following

arthroplasty procedures should evaluate potential benefits and harms, including their impact on

personnel safety (No recommendation/ unresolved issue)



Q27K. AMP DURATION IN THE

PRESENCE OF A DRAIN

Q27K. How does the duration of AMP in the presence of

a drain affect the risk of SSI?

Evidence Summary/Draft Recommendations

Our search did not reveal data that evaluated AMP duration in the presence of

a drain on the risk of SSI in arthroplasty patients.

JUNE 2013 NEW

27k.No recommendation can be made regarding the safety and

effectiveness of AMP duration in the presence of a drain and surgical

site infection in prosthetic joint arthroplasty procedures.




Q35-38. BIOFILM

Q35-38. Biofilm

Q35. What are the most effective strategies for the diagnosis of PJI?

Q35A. Serologic markers

Q35B. Synovial fluid markers

Q35C. Tissue testing

Q36. How effective are some future/evolving diagnostic techniques?

Q36A. Serologic markers

Q36B. Synovial fluid markers

Q36C. Culture enhancement techniques

Q36D. Molecular techniques

Q37 What are the most effective strategies identify biofilm formation?

Q37A. Phenotypic testing techniques

Q37B. Molecular testing techniques



Q35-38. Biofilm

Q38. What are the most effective strategies for preventing biofilm formation?

Q38A. Cement modifications (i.e., antimicrobials, nanoparticle loading)

Q38B. Prosthesis modifications

Q38C. Vaccines

Q38D. Other (i.e., rip inhibitors-signal based biofilm control agents)?



Q38A. How effective are cement modifications in

preventing biofilm formation/SSI?

Evidence Summary

• All surgeries by 1 surgeon in OR without clean air measures and no exhaust suit.

• cefazolin/gentamicin IV preop and postop for 3 days followed by 7 days of oral cefazolin

• No information on SSI pathogens or antimicrobial susceptibility

• Deep SSI may refer to mix of deep incisional SSI and PJI



Study

GRADE

Comparator SSI

2 RCT

Moderate

Cefuroxime loaded

cement vs. plain

cement

Primary TKA

(hybrid)

Parenteral AMP

Meta 2 RCT (N=428)

Deep SSI OR: 0.08; (95% CI: 0.01 – 0.59); p=0.01

1 RCT (N=350) 0/178 vs. 5/162(3.1%); p=0.0238 (non-diabetics) (Chiu 2002)

1 RCT (N=78) 0/41 vs. 5/37(13.5%); p=0.021 (diabetics) (Chiu 2001)

Low Superficial SSI OR: 0.91; 95% CI: 0.18 – 4.55; p=0.90

1 RCT (N=350) 2/178 vs. 2/162; p=1.00 (non-diabetics)

1 RCT (N=78) 1/41 vs. 1/37; p=0.835 (diabetics) (Chiu 2001)

Q38A. How effective are cement modifications in



JUNE 2013 NEW

38A. No recommendation can be made regarding the safety and

effectiveness of antimicrobial loaded cement, prevention of biofilm

formation and surgical site infection in prosthetic joint arthroplasty

procedures. (No recommendation/ unresolved issue)



Q38B. How effective are prosthesis modifications in



Our search did not reveal in vivo data that evaluated the impact of prosthesis

modifications on the risk of biofilm formation or SSI in arthroplasty procedures.

JUNE 2013 NEW

38B. No recommendation can be made regarding safety and

effectiveness of prosthesis modifications (i.e., antimicrobial coating,

galvanic couples, “printing” technologies, nanotechnology) in prevention

of biofilm formation and surgical site infection in prosthetic joint

arthroplasty procedures.




Q38C. How effective are vaccines in preventing biofilm

formation/SSI?


Our search did not reveal in vivo data that evaluated the impact of vaccines on

the risk of biofilm formation or SSI in arthroplasty procedures.

JUNE 2013 NEW

38C. No recommendation can be made regarding safety and

effectiveness of vaccines in prevention of biofilm formation and surgical

site infection in prosthetic joint arthroplasty procedures.




Q38D. How effective are other biofilm control agents in



Our search did not reveal in vivo data that evaluated the impact of other biofilm

control agents on the risk of biofilm formation or SSI in arthroplasty procedures.

JUNE 2013 NEW

38D. No recommendation can be made regarding the safety and

effectiveness of biofilm control agents (i.e., signal-based rip inhibitors)

and surgical site infection in prosthetic joint arthroplasty procedures.




Acknowledgements Core Writing Group

HICPAC Committee

Dale W. Bratzler, DO, MPH

William P. Schecter, MD

Center for Evidence-based Practice, University of Pennsylvania

Craig Umscheid MD, MSCE

Rachel Kelz, MD , MSCE, FACS

Caroline Reinke, MD, MPH

Brian Leas, MA, MS

Sherry Morgan, RN, MLS, PhD

Anne Seymour, MS

Rajender Agarwal, MD

Centers for Disease Control and Prevention

Sandra I. Berríos-Torres, MD

Erin C. Stone, MS

Acknowledgements Content Experts

American Academy of Orthopaedic Surgeons (AAOS)

Javad Parvizi ,MD

John Segreti, MD

American College of Surgeons (ACS)

E. Patchen Dellinger, MD

Association of periOperative Registered Nurses (AORN)

Joan Blanchard, MSS, BSN, RN, CNOR, CIC

George Allen, PhD, CIC, CNOR

Musculolskeletal Infection Society (MSIS)

Elie Berbari, MD

Douglas Osmon, MD

Surgical Infection Society (SIS)

Lena M. Napolitano, MD, FACS, FCCP, FCCM

Kamal Itani, MD

Robert Sawyer, MD

Academic Institutions

Jan A.J.W. Kluytmans, MD (Amphia Hospital, The Netherlands)

John E. Mazuski, MD, PhD (Washington University, St. Louis)

Bernard Morrey, MD (The Mayo Clinic)

Joseph Solomkin, MD (U of Cincinnati)

Staphylococcus aureus (SA) Colonization

Lonneke G.M. Bode ,MD (Erasmus University, The

Netherlands)

Susan Huang, MD (U of California, Irvine)

Jan A.J.W. Kluytmans, MD (Amphia Hospital, The

Netherlands)

Ari Robicsek, MD (Northshore University Health System)

Mark Shirtliff, PhD (University of Maryland)

Margreet Voz, MD (Erasmus University, The

Netherlands)

Jeff Hageman, MHS (CDC)

John A. Jernigan, MD, MS (CDC)

Alex Kallen MD, MPH (CDC)

Biofilm

William Costerton, PhD (Center for Genomic Sciences)

Robin Patel, MD (Mayo Clinic)

Mark Shirtliff, PhD (University of Maryland)

Rodney Donlan, PhD (CDC)

Environmental

Lynne Sehulster, PhD (CDC)

For more information please contact Centers for Disease Control and Prevention

1600 Clifton Road NE, Atlanta, GA 30333

Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348

E-mail: [email protected] Web: http://www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the

Centers for Disease Control and Prevention.

THANK YOU

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