Subcutaneous Gentamycin Implant to Reduce Wound Infections After Loop-Ileostomy Closure: A Randomized, Double-Blind, Placebo-Controlled Trial

Haase, Oliver; Raue, W.; Böhm, Bartholomäus; Neuß, H.; Scharfenberg, Mark; Schwenk, W.

doi:10.1007/s10350-005-0164-z

Cited by 50 publications

(32 citation statements)

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“…Other attempts, such as subcutaneous antibiotic implants (Gentamycin) in the wound, have not shown a relevant reduction in surgical site infections [22] . Another controversy around the subject is the best timing for stoma reversal.…”

Section: Discussionmentioning

confidence: 99%

Increased postoperative complications after protective ileostomy closure delay: An institutional study

Rubio-Perez¹,

León²,

Pastor³

et al. 2014

WJGS

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AIM:To study the morbidity and complications associated to ileostomy reversal in colorectal surgery patients, and if these are related to the time of closure. METHODS:A retrospective analysis of 93 patients, who had undergone elective ileostomy closure between 2009 and 2013 was performed. Demographic, clinical and surgical variables were reviewed for analysis. All complications were recorded, and classified according to the Clavien-Dindo Classification. Statistical univariate and multivariate analysis was performed, setting a P value of 0.05 for significance. RESULTS:The patients had a mean age of 60.3 years, 58% male. The main procedure for ileostomy creation was rectal cancer (56%), and 37% had received preoperative chemo-radiotherapy. The average delay from creation to closure of the ileostomy was 10.3 mo. Postoperative complications occurred in 40% of the patients, with 1% mortality. The most frequent were ileus (13%) and wound infection (13%). Pseudomembranous colitis appeared in 4%. Increased postoperative complications were associated with delay in ileostomy closure (P = 0.041). Male patients had more complications (P = 0.042), mainly wound infections (P = 0.007). Pseudomembranous colitis was also associated with the delay in ileostomy closure (P = 0.003). End-to-end intestinal anastomosis without resection was significantly associated with postoperative ileus (P = 0.037). CONCLUSION:Although closure of a protective ileostomy is a fairly common surgical procedure, it has a high rate of complications, and this must be taken into account when the indication is made. The delay in stoma closure can increase the rate of complications in general, and specifically wound infections and colitis.© 2014 Baishideng Publishing Group Inc. All rights reserved.Key words: Protective ileostomy; Stomas; Stoma-related complications; Surgical infections; Colorectal surgery Core tip: Protective ileostomies are widely used by surgeons for the protection of anastomoses, but they imply a second intervention for reversal. Despite being considered a minor intervention, ileostomy reversal does not lack complications. Adjuvant treatment, complications from the first intervention, or low-priority consideration can delay the closure of the stoma. In our study, we reviewed all complications following ileostomy reversal and found they were considerably high (40%), and increased as did the time (in months) until closure (P = 0.041). In multivariate analysis, male patients had more complications (P = 0.042), mainly wound infections (P = 0.007). Pseudomembranous colitis was also associated with the delay in ileostomy closure (P = 0.003).Rubio-Perez I, Leon M, Pastor D, Diaz Dominguez J, Cantero R. Increased postoperative complications after protective ileostomy closure delay: An institutional study. World J Gastrointest Surg 2014; 6(9): 169-174 Available from:

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Section: Discussionmentioning

confidence: 99%

Increased postoperative complications after protective ileostomy closure delay: An institutional study

Rubio-Perez¹,

León²,

Pastor³

et al. 2014

WJGS

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“…Wounds after stoma closure and perineal wounds after abdominoperineal excisions were contaminated, and the incidence of SSI was high. Haase et al did not show any differential effect between topically-subcutaneouslyused gentamicin implants with regard to the prevention of wound infections after loop-ileostomy closure [18]. However, very good results with topical administration of gentamicin were achieved in more randomized controlled studies [19][20][21].…”

Section: Discussionmentioning

confidence: 99%

TOPICALLY-USED GENTAMICIN ATTACHED TO NANOFIBRE MDOCTM COMPARED WITH GARAMYCIN SCHWAMM<sup>®</sup> IN AN ACUTE WOUND INFECTION MODEL. AN EXPERIMENTAL STUDY.

Lochman¹,

Páral²,

Simkovĭc³

et al. 2012

Mil. Med. Sci. Lett.

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SummaryThe aim of this study was to examine the effect of topically-used gentamicin attached to a biodegradable carrier, formed by micro-dispersed oxidised cellulose (MDOC) in nanofibre form, in acute wound infection treatment and to compare it with Garamycin Schwamm ® . Twelve domestic swines were used in a model of a full-thickness infected dermal wound. The effectiveness of both materials in wound infections caused by Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli was tested. The effectiveness of both gentamicin with MDOC and Garamycin Schwamm ® was comparable in Pseudomonas aeruginosa and Escherichia coli infections according to microbiological cultures findings. With Staphylococcus aureus infections there was a higher percent of negative cultures when MDOC with gentamicin was administered, but without statistical significance (p=0.069). When macroscopically assesed, 100 % of infected wounds treated by gentamicin attached to MDOC were without signs of local infection compared to only 16.7 % when Garamycin Schwamm ® was used and this was statistically significant (p<0.01). For statistical analysis we used a Fisher´s exact test. When combined with a nanofibre MDOC carrier, topically-used gentamicin seems to be rendered more for treatment of full-thickness skin infections. The resulting good haemostatic effect of MDOC was observed.

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“…However, similar analyses could not be completed for other brands. Only two studies used a placebo sponge [10,16].…”

Section: Resultsmentioning

confidence: 99%

“…Twenty-two articles were potentially relevant and were reviewed in detail. Of these, 13 were included in the final analysis [5][6][7][8][9][10][11][12][13][14][15][16][17].…”

Section: Data Extractionmentioning

confidence: 99%

“…A number of studies have examined the efficacy of implanting gentamicin/collagen sponges in surgical incisions to reduce the risk of SSI [2,[5][6][7][8][9][10][11][12][13][14][15][16][17]. Currently, this method of delivering antimicrobial agents is approved in 54 countries and these sponges have been used in more than two million patients; however, they are not approved for use in the United States [18].…”

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confidence: 99%

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Gentamicin/Collagen Sponge Use May Reduce the Risk of Surgical Site Infections for Patients Undergoing Cardiac Operations: A Meta-Analysis

Formanek

Herwaldt

Perencevich

et al. 2014

Surgical Infections

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Objective: A meta-analysis of all published randomized controlled trials of the effectiveness of gentamicin/ collagen sponges for preventing surgical site infections (SSIs). Background: Despite routine use of systemic prophylactic antimicrobial agents, SSIs continue to be associated with substantial morbidity. Results conflict of studies of the efficacy of gentamicin/collagen sponges for preventing SSIs. However, many of these studies have assessed sponge use in only a single specific type of operation. The general effect of sponge use among different types of operations has not been previously assessed. Methods: The PubMed and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases were searched for articles appearing from 1990 through January 2012 that were related to gentamicin/collagen sponge use and SSIs. Summary estimates were obtained through a random effects model. After reviewing 714 article abstracts and reviewing 22 articles in detail, we pooled the odds ratios (OR) for 13 independent study populations (cardiac, n = 4; colorectal, n = 4; pilonidal sinus, n = 2; hernia, n = 2; gastrointestinal, n = 1) in which the association between prophylactic use of gentamicin/collagen sponges and SSIs was assessed. Results: Pooling of the results of all studies included in the review in a random effects model showed a significant protective effect of prophylactic use of gentamicin/collagen sponges against SSI (pooled OR: 0.66; 95% confidence interval [CI]: 0.45, 0.97; n = 13). However, when the data were stratified by type of operation, a significant protective effect was observed in cardiac procedures (pooled OR: 0.59; 95% CI: 0.37, 0.96; n = 4) but not in colorectal procedures (pooled OR: 0.74; 95% CI: 0.29-1.92; n = 4). Conclusion: Use of gentamicin/collagen sponges was associated with a reduced risk of SSI following cardiac operations but not following colorectal procedures. S urgical site infections (SSIs) are among the most common types of healthcare-associated infections [1]. Despite the routine use of systemic prophylactic antimicrobial agents, SSIs continue to be associated with substantial morbidity following various types of surgery. Alternative methods of antimicrobial prophylaxis have therefore been studied, including the application of antimicrobial agents locally within a surgical incision [2][3][4].A number of studies have examined the efficacy of implanting gentamicin/collagen sponges in surgical incisions to reduce the risk of SSI [2,[5][6][7][8][9][10][11][12][13][14][15][16][17]. Currently, this method of delivering antimicrobial agents is approved in 54 countries and these sponges have been used in more than two million patients; however, they are not approved for use in the United States [18]. Gentamicin/collagen sponges are composed of highly purified collagen, and deliver high local concentrations of gentamicin, but without its serum concentration reaching the level of toxicity. The collagen of these sponges is absorbed slowly by the body within 1-8 wks after the...

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Subcutaneous Gentamycin Implant to Reduce Wound Infections After Loop-Ileostomy Closure: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract: Subcutaneous implantation of a gentamycin sponge yields no clinically relevant reduction of the wound infection rate after loop-ileostomy closure so that routine use is not recommended in this procedure.

Cited by 50 publications

References 20 publications

Increased postoperative complications after protective ileostomy closure delay: An institutional study

Increased postoperative complications after protective ileostomy closure delay: An institutional study

TOPICALLY-USED GENTAMICIN ATTACHED TO NANOFIBRE MDOCTM COMPARED WITH GARAMYCIN SCHWAMM<sup>®</sup> IN AN ACUTE WOUND INFECTION MODEL. AN EXPERIMENTAL STUDY.

Gentamicin/Collagen Sponge Use May Reduce the Risk of Surgical Site Infections for Patients Undergoing Cardiac Operations: A Meta-Analysis

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