a.f.j. de bruin
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Gentamicin collagen fleeces (Collatamp/Garacol®)
A.F.J. De Bruin
Abdominalperineal resection (APR).
•Ernest Miles 1908
•Perineal infection up to 70%
Wound infection after APR + RTX
Author Journal APR APR + Rtx
p-value
Marijnen et al J Clin Oncol 2002
18% 29% 0.008
Vallero et al. Int J Colorectal Dis 2003
26% 45% -
Bullard et al. Dis Colon Rectum 2005
23% 47% 0.005
Preoperative radiotherapy multiplies perineal morbidity !
Local gentamicin reduces perineal wound infection after radiotherapy and
abdominoperineal resection
De Bruin AFJ et al. Tech Coloproctol 2008 Dec
Patients underwent complete closure of the pelvic peritoneal floor, sacral drainage and multiple layer wound closure with or
without Garacol®
40 patients undergoing abdominoperineal resection for rectal cancer after
short-course radiotherapy
postoperative deep wound infection or abscess
•Superficial perineal wound complications occurred in 11% of the Collatamp® group and 29% of the control group (p=0.15)
•Only 5% of patients developed a deep wound infection or abscess in Collatamp® group compared with 29% of patients in control group (p=0.05)
0
10
20
30 29%
5%
p=0.05
Control Collatamp®
De Bruin AFJ et al. Tech Coloproctol 2008 Dec.
Patie
nts w
ith p
osto
pera
tive
deep
wo
und
infe
ctio
n or
abs
cess
(%)
Gentamicin collagen fleeces• Aminoglycoside: Strong bactericide • Gram negative: Pseudomonas, Entrobacter, Klebsiella• Gram positive: Staphylococci
• NO effect on osteoblasts
• Gentamicin fleeces (Collatamp®=Garacol®): – Collagen impregnated with Gentamicin– Concentration exsudaat stays high during short period and diminish
fast.– Re-absorbable– Measurements; 5x5 cm(32,gmg) or 10x10cm(130mg) – No biofilm formation
Collagen fleeces
Initiation of haemostasis by tissue factor receptors in renatured collagen
Thrombin
Binding of the platelet collagen receptor to
collagen leads to activation of platelets
Activation of surface glycoprotein
Aggregation of platelets
Polymerised fibrin fibres(clot)
Fibrinolysis: thrombin cleaves fibrinogen allowing fibrin
polymerisation
Hakim NS & Canelo R. (2007) Haemostasis in Surgery. Imperial College Press; Stemberger A et al. Eur J Surg 1997;Suppl 578:17–26
Microbial resistence
3. Stemberger A. Eur J Surg Suppl 1997;578:17-26.
High local concentrations of gentamicin
Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698
Day
Minimum inhibition concentration (MIC)
After implantation of 3 units (total gentamicin sulphate dose
600 mg) into a postoperative abdominal wound
0
2000
Gent
amici
n tis
sue
conc
entra
tion
(mg/
L)
1 2 3 4 5 6 7
Low serum levels of gentamicin
2
1 2 3 4 5 6 7
Minimum inhibition concentration (MIC)4
Gent
amici
n se
rum
co
ncen
tratio
n (µ
g/m
L)
Adapted from Ruszczak Z & Friess W. Adv Drug Deliv Rev 2003;55:1679–1698
Day
After implantation of 3 units (total gentamicin sulphate dose
600 mg) into a postoperative abdominal wound
0
Microscopy collagen matrix pictures
Gentafleece Collatamp
x200 x200
Collatamp’s Collagen Matrix Carrier has a highly
cross-linked Fine-Fibril-Matrix compared to Gentafleece
Diptest data – impact of soaking
0
20
40
60
80
100
120
0 50 100 150 200 250 300 350 400
Immersion time (min)
Gen
tam
icin
Con
tent
Los
t (%
)
Andrew M Lovering, Julie Sunderland; Antimicrobial Reference Laboratory, North Bristol NHS Trust, Bristol, BS10 5NB, United Kingdom
Collatamp® and gastrointestinal (GI) surgery
•Prevention of wound infection in elective colorectal surgery by local application of a gentamicin-containing collagen implant
•Rutten HJ & Nijhuis PH. Eur J Surg Suppl 1997;578:31–35
221 patients undergoing elective colorectal surgerySystemic antibiotic cover with (n=107) or without (n=114)
the use of Collatamp®
Clinically proven efficacy of Collatamp® in GI surgery
•3-fold decrease in wound infection rates; (p<0.01)
•Significantly shorter hospital stay (13.8 days vs 16.3 days; p=0.015)
•No adverse events related to Collatamp®
18.4%
5.6%
p<0.01
0
10
20
30
Systemic antibiotics
only
Collatamp® + systemic antibiotics
Patie
nts w
ith p
osto
pera
tive
woun
d in
fect
ion
(%)
Rutten HJ & Nijhuis PH. Eur J Surg Suppl 1997;578:31–35
Gentamicin collagen Fleeces and gastrointestinal (GI) surgery
• Improvement of perineal wound healing by local administration of gentamicin-impregnated collagen fleeces after abdominoperinealexcision
of rectal cancer
• Gruessner and Clemens, et al. The American Journal of Surgery 2001
97 patients undergoing elective abdominal perineal resection
Systemic antibiotic cover with (n=49) or without (n=48) the use of Collatamp®
•Eradication of enterobacteria, staphylococci and Pseudomonas aeruginosa in 84% of Genta patients versus 60% controls (P 0.013).
•4% Deep wound infection treatment group versus 10% control group
25%
12 %
P=0.01
0
10
20
30
Systemic antibiotics
only
Collatamp® + systemic antibiotics
Patie
nts w
ith p
osto
pera
tive
per
inea
l wou
nd in
fect
ion
(%)
Gruessner, et al. 2001
Postoperative perineal wound infection
Collatamp vs PMMA Chains
local concentrations of gentamicin in the wound (mg/L)
Adapted from Swieringa, et al..(2008)Acta Orthopaedica,79:5,637 —642
MIC for resistent pathogens (300 mg/L)
MIC for sensitive pathogens(4 mg/L)
PMMA Chains
small PMMA Chains
Time
Gent
amic
in ti
ssue
co
ncen
trati
on (m
g/L)
Collatamp®
Biomaterial-associated infection of gentamicin-loaded PMMA beads in
orthopaedic revision surgery
• 20 patients with prosthesis-related infections
• Gentamicin loaded beads in two-stage orthopaedic revision surgery
Daniëlle Neuta,b, Hilbrand van de Belta et al. Journal of Antimicrobial Chemotherapy (2001)
Gentamicin loaded beads
Cocci
• Presence of bacteria on gentamicin loaded beads in 18 of the 20 patients
• 12 of these 18 patients considered free of infection
• 9 cultures MIC >256mg/l
COMPARATIVE EVALUATION OF RESULTS AFTER LOCAL ANTIBIOTIC THERAPY WITH GENTAMYCIN IN FORM OF
BEADS AND FLEECE
D. Bettin et al. J Bone Joint Surg Br 2009
Chronic osteomyelitis
108 patients undergoing debridement and local application of gentamicin
Prospective serie:54 patients PMMA beads group and 54 patient in GCCI group
revision operations
• Local wound healing criteria p=0.34
0
50
100
20 %
67%
p=0.0001
GCCI PMMA beads
D. Bettin et al. J Bone Joint Surg Br 2009
Rev
isio
n op
erat
ions
(%)
Local antibiotic administration in osteomyelitis treatment--a comparative study with two different
carrier substances
Letsch et al. Actualle traumatol 1993
osteomyelitis of long bones
20 patients undergoing debridement and local application of gentamicin
Prospective serie:10 patients PMMA beads group and 10 patient in GCCI group
complete resolution of osteomyelitis
The number of re-operations was significantly group I 1.1 vs 1.9
• Release characteristics: – Group I: Local levels of 1400 mg/l at 6
hours post-insertion & non-therapeutic levels in plasma
– Group II: Local levels of 100 mg/l at 3 hrs post-insertion.
0
50
100
90 % 80%
GCCI PMMA beads
Letsch et al. Actualle traumatol 1993
com
plet
e re
solu
tion
of o
steo
mye
litis
(%)
Evaluation of the impact of COLLATAMP on the incidence of post-operative sternal wound infections
Friberg et al, Ann Thorac Surg 2005
Prospective, randomised, double blind trial (recruited 2000-02)1950 patients analysed (73% CABG, 14% valves)
Primary outcome: all sternal wound infections occurring within
2 months of surgery
Friberg O et al. Ann Thorac Surg 2005;79:153-161
Cardiothoracic surgery
Sternal wound infections at 2 months
• Re-operation rate for infection(p=0.021):– 3,9% control– 2,1 % GCCI(gentamicin
collagen fleeces
Friberg O et al. Ann Thorac Surg 2005;79:153-161.
9
4,3
0
2
4
6
8
10
Systemic antibiotics (n=967) COLLATAMP G + systemicantibiotics (n=983)
Infection rate (%
)
p<0.001
Collatamp® and orthopaedic surgery
Therapy with gentamicin-PMMA beads, gentamicin-collagen sponge,and cefazolin for experimental osteomyelitis due to Staphylococcus aureus in
rats
V. Mendel et al. Arch Orthop Trauma Surg (2005)
Rat model for Staphylococcus aureus-induced osteomyelitis150 rats radiographic confirmed osteomyelitis undergoing debridement and
randomization in to four groups.
Gentamicin; PMMA chains versus Collagen(Collatamp®)
• Goups: – No treatment
– Cefazoline
– Gentamicine PMMA chains + Cefazoline
– Gentamicin collagen fleeces + Cefazoline
Mendel et al. Arch Orthop Trauma Surg 2005
Results after four weeks
• All rats in treatment groups stage 1 infection
• All rats in control group stage 3 en 4
• Bacteriën – Control group: 106 CFU/g– Cefalozine: 104 CFU/g– Gentamicin PMMA102 CFU/g– Gentamicin collagen in 81% no bacteria
Mendel et al. Arch Orthop Trauma Surg 2005
Collatamp® and Pilonidal sinus
•A prospective randomised study comparing two treatment modalities for chronic pilonidal sinus with a 5-year follow-up
•Milind M. Rao &Wojtek Zawislak; Int J Colorectal Dis 2009
60 patients undergoing excision and primary suture of pilonidal sinus
Surgical procedure with (n=30) or without (n=30) the use of Collatamp®
Pain scores
patients healed after 4 weeks
•Mean time to wound healing - Group I: 10 days vs Group II: 50 days (p<0.001)
•LOS: There was no difference seen between the two groups in length of hospital stay
•No difference long-term recurrence rate
p<0.001
13%
90%
0102030405060708090
100
No antibiotics
Prim
ary
heal
ing
rate
(%)
Collatamp®
Milind M. Rao &Wojtek Zawislak; Int J Colorectal Dis 2009
Turkey the place to be for a hairy ass
20%5%
Results
Treatment of groin wound graft infections
3434
• 10 months prospective follow up (range 6-15 months) of 14 cases of graft infection following vascular reconstruction
1 COLLATAMP® implant• Results:
• 13/14 (93%) healed, 1 case failed: required multiple re-operations
• Bacteriology:• 6 Staph aureus• 2 Pseudomonas aeruginosa• 1 non-haemolytic Streptococcus (not sensitive to
gentamicin)• 5 sterile cultures
2. Jørgensen LG et al. Eur J Vasc Surg 1991;5:87-91.
Vascular surgeryJorgensen et al Eur J Vasc Surg 5 1991
Jorgensen et al Eur J Vasc Surg 5 1991
Vaatstudie MUMC/ Atrium• ‘PREVENTION OF SURGICAL SITE INFECTION AT THE GROIN AFTER
FEMORAL• ARTERIAL EXPOSURE USING LOCAL GENTAMYCIN SPONGE• PROSPECTIVE, RANDOMISED, CONTROLLED TRIAL’
• drs. B.J. Telgenkamp (projectleider) Atrium• dr. J.W. Daemen (begeleider) MUMC• drs. A.G. Krasznai (begeleider) Atrium• dr. P. Boelens MUMC
Cost – benefit • Cost 10 cm x 10 cm = 90 €• Adverse impact of SSI
Median LOS without SSI (days)
Extra LOS with SSI*(days)
Extra costs due to SSI (€)
Limb amputation 13.2 21.0 6940
ORLBF 9.6 9.9 3270
Hip prothesis 11.1 11.5 3780
Knee prosthesis 10.3 10.9 3601
*Adjusted by age, sex, preoperative stay, ASA score, wound class, duration operation, multiple procedures, emergency, trauma
Coello et al. J Hosp Infect 2005;60:93-103
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