TITLE: Antibacterial Sutures for Wound Closure after Surgery: A Review of the Clinical Effectiveness and Long-Term Adverse Effects DATE: 17 September 2008 CONTEXT AND POLICY ISSUES: Surgical site infections complicate recovery for more than half a million patients each year in the United States. 1 The optimal wound closure material (suture) should give minimal tissue reaction, should resist infection, and have good elasticity and plasticity to accommodate wound swelling. 2 Suture classifications include non-absorbable or absorbable, natural or synthetic, and multifilament or monofilament. 2 Although some of the newer materials available have many of these properties, no one material is ideal and compromises must be made. Antibacterial, which are coated with antibiotics, were developed to help the wound healing by reducing the risk of surgical site infections. 3,4 The effectiveness of antibacterial is unclear, and complications can occur. 3,5 It is therefore necessary to examine the evidence regarding the clinical effectiveness and adverse effects of antibacterial. RESEARCH QUESTIONS: 1. What is the clinical effectiveness of antibacterial for the prevention of surgical site infections? 2. Are there long-term adverse effects associated with antibacterial suture use including development of drug-resistant bacteria? 3. What are the guidelines for using antibacterial for wound closure? Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information on available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.
METHODS: A limited literature search was conducted on key health technology assessment resources, including PubMed, The Cochrane Library (Issue 3, 2008), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, EuroScan, international health technology agencies, and a focused Internet search. Results include articles published between 2003 and August 2008, and are limited to English language publications only. No filters were applied to limit the retrieval by study type. SUMMARY OF FINDINGS: Clinical effectiveness of antibacterial for the prevention of surgical site infections No health technology assessments, systematic reviews, or meta-analyses on clinical effectiveness of antibacterial were identified. Four studies 6-9 were identified. An openlabel randomized controlled trial (RCT) (published in 2005 but time of trial not reported) was conducted on 147 pediatric patients undergoing various surgical procedures with either polyglactin 910 coated with antibiotic triclosan or polyglactin without triclosan. 6 Endpoints included wound healing characteristics such as infection, pain, and use of antibiotics. Wound healing characteristics were comparable for both, except significantly fewer patients with triclosan reported pain on day one compared with patients without triclosan (p=0.01). Twenty four percent of patients in the triclosan-coated suture group and 31% of patients in the conventional suture group received peri-operative antibiotics. There were no adverse events related to, and there was no difference between treatment groups. Performance of triclosan-coated for the reduction of sternal wound infections on 479 cardiac surgery patients was also determined in a 2005 non-rct. 7 Patients were closed with triclosan-coated or with conventional. All 24 patients who developed sternal infections were in the conventional wound closure group during the study period (mean followup was 7.6 months). A 2006 double-blind RCT was conducted on 26 patients undergoing breast reduction surgery to evaluate the dehiscence incidence rate (the premature opening or splitting along surgical suture lines secondary to poor wound healing) between triclosan-coated and non-triclosan coated suture material. 8 The triclosan-coated were used either on the left or right breast, and the contralateral breast was used as the control. Data were not favourable for triclosan, with wound dehiscence found in 16 cases among the triclosan breasts, whereas seven cases of dehiscence were observed in the control breast (p = 0.023). A 2006 double-blind controlled trial randomly assigned 61 patients requiring central spinal fluid shunt implantation (with a total of 84 shunt procedures) to receive coated polyglactin 910 with triclosan or conventional (polyglactin 910 without triclosan). 9 The shunt infection rate in the triclosan group was 2 of 46 procedures (4.3%) and 8 of 38 procedures (21%) in the control group (p = 0.038). Clinical findings from the above four trials are summarized in the table below. Antibacterial Sutures for Wound Closure after Surgery 2
Table 1: Summary of Findings from the RCTs and Non-RCT on Antibacterial Sutures Studies Design, number of patients Conclusion Ford et al 6 RCT, 147 patients Favoured triclosancoated Fleck et al 7 Non-RCT, 479 Favoured triclosancoated patients Deliaert et al 8 RCT, 26 patients Favoured conventional Rozelle et al 9 RCT, 61 patients Favoured triclosancoated Sponsored by industry for antibacterial Yes Not reported Not reported No Long-term adverse effects of using antibacterial There were no long-term adverse effects, such as development of drug-resistant bacteria, reported in the studies on antibacterial. Guidelines for using antibacterial for wound closure There were no guidelines identified by the literature search on the use of antibacterial for wound closure. Economic evaluations An economic study found the overall cost of a cardiac surgical procedure using conventional was US$11,421, and using triclosan-coated the cost was US$11,430 (the cost of triclosan-coated suture was $30 per patient as compared to $21 per patient for non-triclosan suture). 7 The total cost to treat a sternal wound infection was calculated as US$11,200. The cost for a patient with a sternal wound infection was therefore $11,200 plus the costs of a normal stay (US$11,400), resulting in a total cost of US$22,600. Calculated on a 12-month period at the study centre, a total of 40 patients sustained a sternal wound infection, resulting in an extra cost of 40 * $11,200, or US$448,000 in total. The increased cost of $9 through the use of the triclosan-coated is negligible if even a small percentage of sternal wound infections can be prevented. CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING: Only four studies were identified on the effectiveness of antibacterial. These studies were small size trials and three of these four studies showed the potential of antibacterialcoated in reducing wound infection rate. Despite the fact that surgical wound infection increased cost, the cost-effectiveness of antibacterial-coated remains uncertain. Higher quality research on the effectiveness of antibacterial is needed. Principles of effective wound repair are still primordial for a healthy wound closure. Antibacterial Sutures for Wound Closure after Surgery 3
PREPARED BY: Chuong Ho, MD, MSc, Research Officer Carolyn Spry, MLIS, Information Specialist Health Technology Inquiry Service Email: htis@cadth.ca Tel: 1-866-898-8439 Antibacterial Sutures for Wound Closure after Surgery 4
REFERENCES: 1. Nichols RL. Preventing surgical site infections: a surgeon's perspective. Emerg Infect Dis 2001;7(2):220-4. Available: http://www.cdc.gov:80/ncidod/eid/vol7no2/nichols.htm (accessed 2008 Sep 4). 2. Terhune M. Materials for wound closure. In: emedicine [website]. New York: WebMD; 2007. Available: http://www.emedicine.com/derm/topic825.htm (accessed 2008 Sep 3). 3. Efficacy and cost-effectiveness of antibacterial. In: HTAIS Custom Hotline Responses [database online]. Plymouth Meeting (PA): Economic Cycle Research Institute (ECRI); 2008. 4. Triclosan-coated polyglactin 910 suture (coated VICRYL-Plus-antibacterial suture). In: HTAIS Custom Hotline Responses [database online]. Plymouth Meeting (PA): Economic Cycle Research Institute (ECRI); 2005. 5. Neligan PC. Bioactive. Plast Reconstr Surg 2006;118(7):1645-7. 6. Ford HR, Jones P, Gaines B, Reblock K, Simpkins DL. Intraoperative handling and wound healing: controlled clinical trial comparing coated VICRYL plus antibacterial suture (coated polyglactin 910 suture with triclosan) with coated VICRYL suture (coated polyglactin 910 suture). Surg Infect (Larchmt) 2005;6(3):313-21. 7. Fleck T, Moidl R, Blacky A, Fleck M, Wolner E, Grabenwoger M, et al. Triclosan-coated for the reduction of sternal wound infections: economic considerations. Ann Thorac Surg 2007;84(1):232-6. 8. Deliaert AE, Van den Kerckhove E, Tuinder S, Fieuws S, Sawor JH, Meesters-Caberg MA, et al. The effect of triclosan-coated in wound healing. A double blind randomised prospective pilot study. J Plast Reconstr Aesthet Surg 2008. 9. Rozzelle CJ, Leonardo J, Li V. Antimicrobial suture wound closure for cerebrospinal fluid shunt surgery: a prospective, double-blinded, randomized controlled trial. J Neurosurg Pediatrics 2008;2(2):111-7. Antibacterial Sutures for Wound Closure after Surgery 5