complications associated with bacitracin powder in surgical wounds · data were collected regarding...

clinical articleJ neurosurg Pediatr 16:719–725, 2015

Topical antibiotics have been used in many surgical subspecialties in an attempt to minimize wound in-fection with mixed results.1–3,5,6,10–12,14,15,21,22,24,25,27–29

Our group’s recent 10-year retrospective study showed that the application of bacitracin antibiotic powder to

wounds during CSF shunt surgery was associated with a reduction in shunt infection rates.4 Briefly, two separate 5-year periods in which bacitracin was and was not sys-tematically applied to shunt wounds were analyzed using both univariate and multivariate analyses. Independent

abbreviations eGFR = estimated glomerular filtration rate; HR = hazard ratio. submitted December 12, 2014. accePted April 24, 2015.include when citing Published online September 18, 2015; DOI: 10.3171/2015.4.PEDS14699.

Complications associated with bacitracin powder in surgical woundsJoshua m. beckman, md,1 ernest K. amankwah, Phd,3,5 lisa l. tetreault, rn,3,4 sharon a. Perlman, md,2 and gerald F. tuite, md1,4,5

1Department of Neurosurgery and Brain Repair and 2Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, Florida; 3Department of Clinical and Translational Research, and 4Neuroscience Institute, All Children’s Hospital/Johns Hopkins Medicine, St. Petersburg, Florida; and 5Department of Pediatrics, Johns Hopkins Medicine, Baltimore, Maryland

obJect There has been renewed interest in the application of concentrated antibiotic powder to surgical wounds as a method to decrease infection rates. While there is substantial medical literature describing the effectiveness and com-plications associated with vancomycin and gentamycin powders, very little has been reported regarding the safety and effectiveness of bacitracin powder in surgical wounds. In this paper the authors report their detailed analysis of potential bacitracin powder–related complications in a population of pediatric patients who underwent shunt surgery.methods A detailed retrospective analysis was completed of all CSF shunt surgeries performed by the corresponding author at a large children’s hospital between 2001 and 2013. This cohort consisted of many patients who were the sub-ject of a previous report that showed the use of bacitracin powder in shunt wounds potentially decreased infection rates. Data were collected regarding the most common known complications of bacitracin, i.e., anaphylaxis, wound healing difficulties, and renal dysfunction. Data were stratified by typical demographic, medical, and surgical variables, including whether bacitracin powder was applied to wounds prior to closure.results A total of 597 patients were reviewed in the analysis: 389 underwent surgery without bacitracin powder and 208 had concentrated bacitracin powder applied to the wounds prior to closure. The application of bacitracin powder was not associated with anaphylaxis (n = 0 both groups) or with an increase in wound breakdown (n = 5 in the control group, n = 0 in the bacitracin powder group) or renal dysfunction (creatinine/estimated glomerular filtration rate) using both comparative and multivariate analyses between the 2 groups. The sample size evaluating renal function was significantly lower (range 6–320) than that of anaphylaxis and wound breakdown analysis because only clinical values acquired dur-ing the routine care of these patients were available for analysis. The only significant difference in demographics was the more frequent use of intrathecal vancomycin and gentamycin in patients who received bacitracin powder (n = 1 for controls, n = 21 for bacitracin powder). In the multivariate analysis, only 1 factor, surgery performed on a premature infant within the first 3 months of life, was independently associated with a change in creatinine at 3 months (creatinine decreased by 0.18) compared with the level before surgery (p < 0.0001). Bacitracin powder was not a significant factor.conclusions To the authors’ knowledge, this is the first study to systematically analyze the potential complications of concentrated bacitracin powder applied to surgical wounds. The use of topical bacitracin powder in CSF shunt wounds was not associated with anaphylaxis, wound breakdown, or renal dysfunction. Further study using standardized proto-cols is necessary before widespread use can be recommended.http://thejns.org/doi/abs/10.3171/2015.4.PEDS14699Key words hydrocephalus; cerebrospinal; infection; antibiotic; powder; bacitracin

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J. m. beckman et al.

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risk factors for shunt infection included the presence of a tracheostomy or a gastrostomy tube. The only protective factor for shunt infection was the application of bacitracin powder just prior to wound closure.4 Future randomized controlled trials have been suggested before the use of topical antibiotics can be widely recommended.

The properties of bacitracin make it an ideal candidate for local administration. At a concentration of 200 U/ml, bacitracin demonstrated a bactericidal “kill” of greater than 90% at 1 hour and 50% after only 1 minute.9,16,17 Bacitracin also exhibits some detergent properties (which is why it causes solutions to froth). Experiments have shown a 54% reduction in bacterial adherence after only a 30-minute exposure to bacitracin. Therefore, the use of local bacitracin combines both bactericidal and adherence reduction properties to prevent infection.13,17

The complications of intravenous and intramuscu-lar bacitracin have been well described, including renal dysfunction, anaphylaxis, and impaired wound heal-ing.18–20,23,30 However, the potential adverse effects from topical administration of bacitracin into wounds has not been extensively studied. To more thoroughly address these concerns, we further scrutinized the medical records from our patient cohort in the bacitracin powder shunt study,4 specifically analyzing patient outcomes related to the potential complications of using topical high-dose bacitracin powder.

methodsstudy Population

This study was approved by the Institutional Review Board of All Children’s Hospital in St. Petersburg, Flor-ida. In the current study, we reanalyzed the same patient cohort previously used to study the effect of bacitracin powder on CSF shunt infection rates in children over a 10-year period.4 Of the 658 patients who underwent sur-gery by the corresponding author (G.F.T.) at All Children’s Hospital during that time period, we previously reported on 539 patients who had at least 180 days of follow-up, to assess shunt infection. In the current study of the possible complications associated with bacitracin powder use, we included patients with a minimum follow-up of 90 days, which allowed us to analyze 597 of the 658 patients who underwent surgery during the designated time period.

data collectionA retrospective chart review of all cranial shunt pro-

cedures between January 2001 and March 2013 was per-formed to specifically assess preoperative and postoperative renal function, anaphylaxis, and wound breakdown. Our re-review of the patient data included detailed analysis of operative reports, anesthesia records, physician and nursing notes, and laboratory values, carefully searching for any signs of wound breakdown, anaphylaxis, or renal dysfunction.

All procedures were performed at a freestanding chil-dren’s hospital and included patients’ ages, ranging from 1 day to 24 years. This was a primarily pediatric popula-tion, with the exception of a few adults who could not be transferred during acute shunt malfunction.

Bacitracin powder was systematically applied to all

shunt wounds prior to closure between 2008 and 2013, whereas no antibiotic powder was applied to wounds prior to 2008. When bacitracin powder was used in this study, it was placed in all wounds but not in a precise dose-depen-dent manner. Our intent was to fill each wound completely with bacitracin powder. Typically, an entire bottle (50,000 units) was dispersed among the wounds of children of adult size, while smaller doses were used for infants. For neonates and young children, approximately one-half of a bottle (25,000 units) was required to fill the wounds. For mini-open laparotomies, the rectus sheath was closed pri-or to bacitracin powder administration to avoid intraperi-toneal contamination. Please refer to our previous study for the precise surgical technique.4

Renal function was determined by recording preop-erative creatinine and estimated glomerular filtration rate (eGFR) and comparing those values to both the immedi-ate postoperative and 3-month follow-up. The glomerular filtration rate was estimated using the modified Schwartz estimating equation [eGFR = (0.413 × height [in cm])/serum creatinine (mg/dl)].26 Preoperative creatinine and eGFR were defined as values obtained within 2 days of surgery; immediate postoperative creatinine and eGFR were defined as values obtained within 1 week of surgery; and delayed creatinine and eGFR were defined as values obtained at approximately 3 months (± 1 month) after sur-gery. Creatinine values were derived from review of the medical records, reflecting blood levels that were routinely measured in the course of the patients’ routine medical care. No effort was made to measure additional levels for the purpose of this study.

All inpatient and outpatient records were carefully scrutinized for any clinical notes from nephrology within 1 year of surgery. If there were any notes from nephrol-ogy, they were analyzed for any suggestion of new renal dysfunction after surgery.

statistical analysisData were analyzed to compare changes in creatinine

and eGFR between the different time periods within and between the 2 treatment groups (bacitracin powder vs no bacitracin powder used). Numerical variables were compared using the Wilcoxon-Mann-Whitney test and categorical variables were compared using chi-square or Fisher’s exact tests. Multivariate linear regression models were used to assess the effect of the following factors on the change in creatinine at 1 week and at 3 months when compared with creatinine before surgery: age, sex, opera-tion performed on a premature infant within the first 90 days of life, number of shunt operations within 90 days of index operation, operative time, use of intrathecal vanco-mycin and gentamycin, and use of bacitracin powder. This multivariate analysis was designed a priori, based on the analyzable factors that were believed could influence renal function and/or have been described in previous studies to be related to renal function in this setting. We did not re-port a similar multivariate analysis of eGFR because there was so much missing data related to height in the control group. All statistical analyses were performed using SAS (version 9.3, SAS Institute Inc.) and p values < 0.05 were considered statistically significant.


bacitracin complications in surgical wounds

J neurosurg Pediatr Volume 16 • December 2015 721

resultsOur database contained information on 597 shunt pro-

cedures (initial and revision) performed by the correspond-ing author between 2001 and 2013. Three hundred eighty-nine patients underwent surgery without bacitracin powder and 208 had concentrated bacitracin powder applied to the wounds prior to closure. Renal function was measured pre-operatively (n = 237 for controls, n = 172 for bacitracin), immediately postoperatively (n = 320 for controls, n = 98 for bacitracin), and at least 3 months postoperatively (n = 104 for controls, n = 77 for bacitracin) in both the historical control group (no powder) and the bacitracin powder group. It is atypical for these values to be measured in a pediatric population, but when available, they were recorded. This is noted in Table 1, in which varying numbers of patients were evaluated for renal function (range 6–320 patients). There were no statistically significant differences in the demo-graphics between the patients who did and did not receive bacitracin powder (including baseline renal dysfunction or the incidence of spina bifida), except for more frequent use of intrathecal vancomycin and gentamycin in the patients who received bacitracin powder (Table 2). Intrathecal an-tibiotics always included both vancomycin and gentamy-cin given dose-dependently: if the patient was less than 3 months of age, 5 mg of vancomycin and 1 mg of gentamy-cin were given; if the child was older than 3 months, 10 mg of vancomycin and 2 mg of gentamycin were given.

comparison of creatinine and egFr between the control and bacitracin Powder groups at 3 different time intervals

There were no statistically significant differences in

creatinine when comparing levels drawn before surgery, within the first week of surgery, and at 3 months after sur-gery. This was a consistent finding when comparing the overall results. However, when stratifying the data accord-ing to whether bacitracin powder was administered, there was a significant difference in the values found within the first week of surgery (median 0.50 in the control group vs 0.41 in bacitracin powder group; p < 0.001; Table 1). When performing the same analysis with eGFR, there were no statistically significant differences in eGFR when com-paring the eGFR levels between the groups at any time interval (Table 1).

comparing the change in creatinine and egFr between the control and bacitracin Powder groups

When calculating the change in creatinine for each pa-tient over time, there were no statistically significant dif-ferences when comparing the patients who had bacitracin powder to those who did not (Table 1). For patients who had creatinine levels before and after surgery, the medi-an change in creatinine in the control group (no powder) immediately after surgery and at 3 months was zero. In patients who received bacitracin powder, there was no increase in creatinine in the immediate postoperative pe-riod and a median decrease of 0.01 mg/dl at 3 months when compared with their levels drawn before surgery (Table 1).

Calculating eGFR requires not only creatinine levels but also the patient’s height. Because height measurements were often not recorded in the early cohort (no powder), comparisons of eGFR between patients who did and did not receive bacitracin powder are limited. Given these

table 1. comparison of complications between control and powder groups

VariableNo Powder Bacitracin Powder

p ValueTotal Median (range) Total Median (range)

Anaphylaxis (no/yes) 389 208 No 389 208 Yes 0 0Wound breakdown 389 208 0.17 No 384 208 Yes 5 0Creatinine (mg/dl) Before surgery 237 0.40 (0.2–1.1) 172 0.40 (0.1–6.1) 0.89 First week 320 0.50 (0.1–1.3) 98 0.41 (0.1–8.1) <0.001 3 mos 104 0.40 (0.2–1.0) 77 0.37 (0.1–0.9) 0.31Change in creatinine in first wk* 210 0.00 (−0.5 to 0.4) 84 −0.01 (−0.2 to 2.0) 0.30Change in creatinine in 3 mos† 76 0.00 (−0.3 to 0.3) 69 0.00 (−0.5 to 0.6) 0.52eGFR (ml/min) Before surgery 31 135.7 (19.1–210.4) 136 119.8 (9.55–425.3) 0.81 First wk 27 97.9 (20.3–217.3) 75 124.5 (7.19–325.8) 0.50 3 mos 12 119.3 (36.0–275.0) 64 124.1 (54.1–429.0) 0.53Change in eGFR in first wk* 24 0.00 (−68.6 to 72.4) 69 2.62 (−97.7 to 66.7) 0.12Change in eGFR in 3 mos† 6 −26.4 (−70.3 to 110.0) 54 8.37 (−71.1 to 52.1) 0.09

* Value in first week subtracted from value before surgery.† Value at 3 months subtracted from value before surgery.




limitations, when analyzing the change in eGFR for each patient over time, the median eGFR remained unchanged in the control group in the initial postoperative period but it increased by 2.62 ml/min in the patients who had baci-tracin powder (p = 0.12). At 3 months, the median eGFR decreased in the control patients (no powder) but increased in the patients who received bacitracin powder. Unfortu-nately, the limited height data available from the control group limits the conclusions that can be drawn regarding changes in eGFR (Table 1).

comparing renal Function between Participants who received intrathecal antibiotics within the bacitracin Powder cohort

Few patients received intrathecal antibiotics within the bacitracin cohort (n = 21). This relatively small sample size leads to very limited conclusions. Notwithstanding, there was no significant change in renal function defined by creatinine and eGFR between the preoperative state and both the immediate postoperative period and 3-month follow-up for either the intrathecal antibiotic subgroup or the nonintrathecal antibiotic subgroup (Table 3).

multivariate analysis of Factors related to a change in creatinine

Lastly, as part of an a priori hypothesis, a multivari-ate analysis of all patients was performed to determine if other factors could contribute to a change in creatinine from the preoperative value to both the immediate postop-erative and delayed postoperative values (Table 4). Once again, due to the unpredictable pattern of collecting renal function values in these patients, our sample size was only 290 at 1 week and 145 at 3 months. Only surgery per-formed on a premature infant within the first 3 months of life was associated with a significant change in creatinine at 3 months compared with the level before surgery (p < 0.0001). The use of bacitracin powder was not signifi-cantly associated with a change in creatinine at either time interval in this model.

Post hoc analysisTo determine a change in creatinine in the first week

after surgery, with 290 participants included in the multi-variate linear regression and 8 predictors, we had greater than 90% power to observe a change of 0.02 in creati-nine with a standard error of 0.02 at the 2-sided a level of 0.05. To determine a change in creatinine after the first 3 months of surgery, with 145 participants included in the multivariate linear regression and 8 predictors, we had greater than 90% power to observe a change of 0.02 in creatinine with a standard error of 0.02 at the 2-sided a level of 0.05.

nephrology consultations for new renal dysfunction after surgery

Only 2 patients had a new nephrology consultation af-ter their shunt operation, neither of which was related to new renal dysfunction after their operation. One patient was evaluated by a nephrology specialist because of recur-rent urinary tract infections and the other was examined because of chronically low bone mineral density.

discussionOur group began applying concentrated bacitracin

powder to all CSF shunt wounds more than 6 years ago. Our retrospective analysis of shunt infection over 10 years, divided between periods when bacitracin was and was not used, suggested that a reduction in shunt infection was at least partially associated with the use of bacitracin pow-der.4 However, given the limitations of a retrospective study, prospective controlled trials are required before this practice can be broadly recommended. We conducted the analysis in this report to further study the possible com-plications associated with applying high-dose bacitracin directly to surgical wounds prior to closure. This safety information is important for future studies.

Our current study confirmed both our clinical impres-sion and preliminary analysis, i.e., that the application of concentrated bacitracin powder in high doses was not as-sociated with anaphylaxis or an increased rate of wound breakdown or renal dysfunction. Both comparative and multivariate analyses showed that bacitracin powder was not associated with an increase in creatinine (Tables 1

table 2. variable frequency with and without bacitracin powder

Variable No PowderBacitracin Powder p Value

No. of patients 389 208Age (mos) 0.32 Median 105 82 Range 0.03–290 0.07–250Sex (%) 0.79 Female 197 (51) 103 (50) Male 192 (49) 105 (50)Spina bifida (%) 0.25 No 319 (84) 166 (80) Yes 60 (16) 41 (20) Missing 10 1Premature infant (%)* 0.08 No 361 (95) 198 (95) Yes 19 (5) 10 (5) Missing 9 (2) 0History of renal dysfunction (%) 0.07 No 389 (100) 206 (99) Yes 0 (0) 2 (1)Operative time (min) 0.33 Median 41 42 Range 3–267 15–146Mean shunt revisions within 90

days ± SD0.7 ± 1.3 0.5 ± 0.9 0.07

Intrathecal vancomycin & gentamycin (%)

<0.001

No 388 (100) 187 (90) Yes 1 (0) 21 (10)

* Surgery performed on a premature infant within the first 90 days of life.




and 4). Furthermore, a significant change in creatinine was only associated with premature infants undergoing surgery in the first 90 days of life. This finding of signifi-cant fluctuations in creatinine in premature infants is not surprising, considering the dramatic changes in creatinine that normally occur shortly after birth.8

To our knowledge, this is the first study to systemati-cally analyze the safety of high-dose bacitracin powder applied to surgical wounds prior to closure. Our analysis of wound breakdown and anaphylaxis was straightfor-ward, but the analysis of renal function was more diffi-cult because of the retrospective nature of this study. The greatest limitation of our study is related to the large num-ber of missing creatinine levels, which are not uniformly drawn on all patients undergoing shunt surgery, before or after the operation. Our sample size varied greatly, rang-

ing from 6 to 320 (Table 1). It is theoretically possible that patients might have developed renal dysfunction without a creatinine level being drawn within 3 months of surgery. However, we believe it is unlikely given that no patient had a nephrologist consultation for new renal dysfunction after surgery.

Another limitation to our study is related to the way we measure the effect of bacitracin on the kidneys. While the measurement of creatinine is the most widely used marker of renal function, it is an imperfect marker.8 For example, it is not sensitive to small changes in renal function and is linked to muscle mass and body weight, which can vary greatly in newborns.8 Estimating the glomerular filtration rate, on the other hand, takes patient height into account and is believed to be a better measure of renal function. Unfortunately, patient heights were rarely recorded in the

table 3. comparison of renal function between participants who received intrathecal antibiotics in the bacitracin powder group

VariableNo Intrathecal Antibiotic Intrathecal Antibiotic

p ValueTotal Median (range) Total Median (range)

No. of cases 187 21Creatinine (mg/dl) Before surgery 155 0.42 (0.1–6.1) 17 0.32 (0.14–0.54) 0.02 First week 85 0.43 (0.1–8.1) 13 0.33 (0.13–0.49) 0.038 3 mos 68 0.38 (0.1–0.9) 9 0.31 (0.13–0.48) 0.30Change in creatinine in first wk* 73 −0.02 (−0.22 to 2.00) 11 0.00 (−0.06-0.11) 0.45Change in creatinine in 3 mos† 60 0.00 (−0.49 to 0.55) 9 0.02 (−0.23-0.16) 0.25eGFR (ml/min) Before surgery 123 121.67 (9.55–425.33) 13 105.13 (35.91–238.95) 0.38 First week 65 127.54 (7.19–325.77) 10 83.90 (35.91–168.38) 0.048 3 mos 56 128.56 (54.14–429.0) 8 91.81 (62.58–257.33) 0.13Change in eGFR in first wk* 60 3.29 (−97.73 to 66.66) 9 0.00 (−33.49 to 31.57) 0.31Change in eGFR in 3 mos† 48 8.74 (−71.05 to 51.11) 6 3.36 (−9.49 to 52.05) 1.00

* Value in first week subtracted from value before surgery.† Value at 3 months subtracted from value before surgery.

table 4. risk factors for change in creatinine level determined by multivariate analysis

Variable

Change in CreatineFirst Week (n = 290)† 3 Mos (n = 145)‡

Estimate SEM p Value Estimate SEM p Value

Age 0.00 0.00 0.16 0.00 0.00 0.09Sex −0.03 0.02 0.08 −0.01 0.02 0.51Premature* −0.05 0.03 0.14 −0.18 0.04 <0.0001Spina bifida 0.00 0.03 0.96 0.01 0.03 0.85Shunt operations within 90 days −0.01 0.01 0.12 0.00 0.01 0.60Operative time 0.00 0.00 0.44 0.00 0.00 0.49Intrathecal antibiotics −0.01 0.05 0.80 0.05 0.04 0.29Bacitracin powder 0.02 0.02 0.31 −0.02 0.02 0.46

SEM = standard error of the mean.* Surgery performed on a premature infant within the first 90 days of life.† Immediate postoperative value subtracted from preoperative value.‡ Delayed postoperative value subtracted from preoperative value.




control group, which consisted of patients who had surgery in the early 2000s, when electronic medical record entries were less robust than they were in the later cohort. This resulted in a significant amount of missing data for the eGFR in our historical cohort. However, when we strictly analyzed patients who only received bacitracin powder, who underwent surgery more recently and consequently had their heights routinely recorded, their average eGFRs actually increased during the 3 months after surgery (Ta-ble 1).

The potential for nephrotoxicity has been documented with both intravenous and intramuscular administration of bacitracin.18–20,23,30 Ericsson et al. also evaluated its use in peritoneal lavage for preventing laparotomy infections. In their small series of 9 patients, 50,000 units of bacitracin was mixed with 200 ml of normal saline and used as la-vage in the peritoneal cavity. Peak concentrations after 15 minutes exceeded that of intramuscular doses and were tantamount to intravenous administration of bacitracin.7 Consequently, they recommend extreme caution when us-ing bacitracin in the peritoneal cavity. Bacitracin has been essentially abandoned as a systemic antibiotic and promot-ed for local use.

In our study, it was common for 50,000 units of baci-tracin to be dispersed among all the shunt wounds in each patient. Although we did not directly measure serum levels of bacitracin (this lab value was not available at our insti-tution), there were no significant clinical effects encoun-tered with its local administration. This is not surprising given the location and size of shunt wounds. The majority of bacitracin powder was placed in the subgaleal space of the small cranial wounds after meticulous hemostasis was achieved. Even with the potential of tracking along the shunt tubing, a significant amount of systemic absorption is still unlikely to equal that of intramuscular or perito-neal absorption due to the nature of the tissue in which the shunt resides.

Both the trocar technique and mini-open laparotomy technique were used for peritoneal placement of the dis-tal catheter. For the trocar method, the incision is just too small for a significant amount of bacitracin powder to track into the peritoneum, and for the mini-open laparot-omy technique, bacitracin was only applied after the rec-tus sheath was closed. Therefore, no significant amount of powder could reach the peritoneal cavity.

conclusionsThe use of local bacitracin powder in CSF shunt wounds

was not associated with anaphylaxis, wound breakdown, or renal dysfunction. Further study using standardized protocols is necessary before widespread use of bacitracin powder can be recommended.

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disclosureThe authors report no conflict of interest concerning the materi-als or methods used in this study or the findings specified in this paper.

author contributionsConception and design: Tuite, Perlman. Acquisition of data: Tuite, Tetreault. Analysis and interpretation of data: Tuite, Beck-man, Perlman. Drafting the article: Beckman. Critically revising the article: all authors. Reviewed submitted version of manu-script: all authors. Approved the final version of the manuscript on behalf of all authors: Tuite. Statistical analysis: Amankwah. Administrative/technical/material support: Tuite, Beckman, Tet-reault. Study supervision: Tuite.

correspondenceGerald Tuite, Neuroscience Institute, All Children’s Hospital, 601 5th St. S, Ste. 511, St. Petersburg, FL 33701. email: [email protected].


complications associated with bacitracin powder in surgical wounds · data were collected regarding...

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