CADTH RAPID RESPONSE REPORT: SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds: Clinical Effectiveness and Guidelines

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1 CADTH RAPID RESPONSE REPORT: SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds: Clinical Effectiveness and Guidelines Service Line: Rapid Response Service Version: 1.0 Publication Date: September 13, 2017 Report Length: 10 Pages

2 Authors: Charlotte Wells, Andrea Ryce Cite As: The use of medical glue to close surgical wounds: clinical effectiveness and guidelines. Ottawa: CADTH2017 Sep. (CADTH rapid response report: summary of abstracts). Acknowledgments: Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH. CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials. This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites. Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada s federal, provincial, or territorial governments or any third party supplier of information. This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user s own risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors. About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system. SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 2

3 Research Questions 1. What is the comparative clinical effectiveness of medical glue versus staples to closing surgical wounds? 2. What are the evidence-based guidelines regarding the use of medical glue to close surgical wounds? Key Findings Four systematic reviews, six randomized controlled trials, and two non-randomized studies were identified regarding the use of medical glue to close surgical wounds. Methods A limited literature search was conducted on key resources including PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. Methodological filters were applied to a focused search to limit retrieval to health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, non-randomized studies, and guidelines. A second broader search was also included with methodological filters applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, and guidelines. For both searches, where possible, retrieval was limited to the human population. The searches were also limited to English language documents published between January 1, 2012 and August 28, Selection Criteria One reviewer screened citations and selected studies based on the inclusion criteria presented in Table 1. Table 1: Selection Criteria Population Intervention Comparator Outcomes Study Designs Patients who have undergone surgery Medical glue Q1: Staples Q2: No comparator Q1: Clinical effectiveness (benefit or harm), safety Q2: Guidelines Health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, nonrandomized studies, evidence based guidelines Results SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 3

4 Rapid Response reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials, non-randomized studies, and evidence-based guidelines. Four systematic reviews, six randomized controlled trials, and two non-randomized studies were identified regarding the use of medical glue to close surgical wounds. No relevant health technology assessments or evidence-based guidelines were identified. Additional references of potential interest are provided in the appendix. Overall Summary of Findings Four systematic reviews, 1-4 six randomized controlled trials, 5-10 and two non-randomized studies were identified regarding the use of medical glue to close surgical wounds. Detailed study characteristics are provided in Table 2. Nine studies focused on the use of surgical glue in hernia repair, 1-7,9-10 one study focused on caesarean sections, 12, one focused on thyroidectomies, 8 and one focused on spinal surgery. 11 Medical glues appear to be a viable alternative to staples in these surgeries, and often are associated with lower pain when compared to staples. 2-6,8,10 Table 2: Summary of Included Studies on the Comparative Clinical Effectiveness of Medical Glue versus Staples to Close Surgical Wounds First Author, Year Shi, Li, Shah, Study Characteristics Patients requiring transabdominal preperitoneal repair of inguinal hernia Four RCTs (N = 430) and six NRSs (N = 8637) Patients having laparascopic inguinal hernia repair 8 RCTs (N = 1228) Mesh fixation in laparoscopic (totally extraperitoneal and transabdominal pre-peritoneal) groin hernia repair 5 RCTs (N = 491) and 5 NRS (N = 1034) Interventi on(s) Compar ator(s) Systematic Reviews and Meta-Analyses Outcome(s) Fibrin Glue Staples Hernia recurrence Chronic inguinal pain Seroma or hematoma formation Operating time Tissue adhesion fixation Tissue glue Staples Pain Recurrence Hematoma or seroma formation Wound infection Tacks/Stap les Pain Recurrence Seroma or hematoma formation Conclusion(s) The study concluded that fibrin glue may be used an alternative to staples in transabdominal preperitoneal repair of inguinal hernia without increasing post-operative morbidity There was no statistically significant difference between any outcome except in favour of fixation for chronic post-operative pain There was a reduction in pain with tissue glue and no difference in recurrence rates between glue and staples SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 4

5 First Author, Year Kaul, Chan, Subwongcharo en, Tolver, Yang, Brugger, Study Characteristics Patients undergoing laparoscopic inguinal hernia surgery Four studies (N = 662 repairs) Patients undergoing laparoscopic total extraperitoneal hernioplasty N = 130 Patient undergoing totally extraperitoneal laparoscopic inguinal hernia repair N = 60 Patients undergoing transabdominal preperitoneal groin hernia repair N = 112 (N = 100 for analysis) Patients undergoing thyroidectomy N = 132 Patients undergoing transabdominal preperitoneal inguinal Interventi on(s) Compar ator(s) Outcome(s) Fibrin sealant Staples Pain Recurrence Operative time Seroma formation Hospital stay Return to normal activities Randomized Controlled Trials Fibrin sealant Staples Pain Analgesic requirements Seroma formation Recurrences QoL N-butyl-2- cyanoacrylate Fibrin glue Tissue adhesive Tissue adhesive Staples Pain Complications Recurrence Tack fixation Surgical staples Titanium spiral tacks Pain Fatigue Discomfort Nausea/vomiti ng Recurrence Foreign body sensation Operative time Pain Wound dehiscence and infection Cosmetic outcome Patient satisfaction Pain Morbidity Recovery time Conclusion(s) There was no advantage of staples over fibrin glue, except in chronic pain Both methods were effective for mesh fixation, but fibrin sealant was associated with less acute pain Complications and recurrence were not different between N-butyl- 2-cyanoacrylate and staples, although staples appeared to cause more pain when compared to glue Fibrin glue had a better early postoperative outcome than staples/tacks Tissue adhesive was reliable, took longer to perform, lead to lower postoperative pain, and had higher patient satisfaction when compared to staples Hypoesthesia was reduced with the use of tissue adhesive SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 5

6 First Author, Year Study Characteristics hernia repair N = 80 Fortelny, Patients undergoing transabdominal preperitoneal hernioplasty N = 89 Ando, Patients undergoing spinal surgery N = 609 Siddiqui, Patients undergoing caesarean delivery N = 211 Interventi on(s) Compar ator(s) Outcome(s) Fibrin sealant Staples QoL Pain Recurrence Non-Randomized Studies 2-Octylcyanoacrylate Metal staples Surgical site infection Dermabond Staples Wound separation Surgical site infection Conclusion(s) Fibrin sealants had a low rate of recurrence and tissue trauma, and pain appeared to be lower with fibrin sealant compared to staples Wound closure with glue was associated with lower surgical site infections Wound separation was lower with Dermabond, but not significantly MA = Meta-analysis; NRS = non-randomized studies; RCT = randomized controlled trials; SR = systematic review; QoL = quality of life References Summarized Health Technology Assessments No literature identified. Systematic Reviews and Meta-analyses 1. Shi Z, Fan X, Zhai S, Zhong X, Huang D. Fibrin glue versus staple for mesh fixation in laparoscopic transabdominal preperitoneal repair of inguinal hernia: a meta-analysis and systematic review. Surg Endosc Feb;31(2): PubMed: PM Li J, Ji Z, Zhang W. Staple fixation against adhesive fixation in laparoscopic inguinal hernia repair: a meta-analysis of randomized controlled trials. Surg Laparosc Endosc Percutan Tech Dec;25(6): PubMed: PM Shah NS, Fullwood C, Siriwardena AK, Sheen AJ. Mesh fixation at laparoscopic inguinal hernia repair: a meta-analysis comparing tissue glue and tack fixation. World J Surg Oct;38(10): PubMed: PM Kaul A, Hutfless S, Le H, Hamed SA, Tymitz K, Nguyen H, et al. Staple versus fibrin glue fixation in laparoscopic total extraperitoneal repair of inguinal hernia: a systematic review and meta-analysis. Surg Endosc May;26(5): PubMed: PM SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 6

7 Randomized Controlled Trials 5. Chan MS, Teoh AY, Chan KW, Tang YC, Ng EK, Leong HT. Randomized doubleblinded prospective trial of fibrin sealant spray versus mechanical stapling in laparoscopic total extraperitoneal hernioplasty. Ann Surg Mar;259(3): PubMed: PM Subwongcharoen S, Ruksakul K. A randomized controlled trial of staple fixation versus N-butyl-2-cyanoacrylate fixation in laparoscopic inguinal hernia repair. J Med Assoc Thai Mar;96 Suppl 3:S8-13. PubMed: PM Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc Aug;27(8): PubMed: PM Yang YL, Xiang YY, Jin LP, Pan YF, Zhou SM, Zhang XH, et al. Closure of skin incision after thyroidectomy through a supraclavicular approach: a comparison between tissue adhesive and staples. Scand J Surg. 2013;102(4): PubMed: PM Brugger L, Bloesch M, Ipaktchi R, Kurmann A, Candinas D, Beldi G. Objective hypoesthesia and pain after transabdominal preperitoneal hernioplasty: a prospective, randomized study comparing tissue adhesive versus spiral tacks. Surg Endosc Apr;26(4): PubMed: PM Fortelny RH, Petter-Puchner AH, May C, Jaksch W, Benesch T, Khakpour Z, et al. The impact of atraumatic fibrin sealant vs. staple mesh fixation in TAPP hernia repair on chronic pain and quality of life: results of a randomized controlled study. Surg Endosc Jan;26(1): PubMed: PM Non-Randomized Studies 11. Ando M, Tamaki T, Yoshida M, Sasaki S, Toge Y, Matsumoto T, et al. Surgical site infection in spinal surgery: a comparative study between 2-octyl-cyanoacrylate and staples for wound closure. Eur Spine J Apr;23(4): Available from: PubMed: PM Siddiqui DS, Lacuna EM, Chen HY, Chauhan SP. Skin closure of pfannenstiel incision with dermabond, staples, or suture during cesarean delivery: experience of a single attending. Am J Perinatol Mar;30(3): PubMed: PM Guidelines and Recommendations No literature identified. SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 7

8 Appendix Further Information Health Technology Assessments Unclear Comparator 13. Edwards SJ, Crawford F, van Velthoven MH, Berardi A, Osei-Assibey G, Bacelar M, et al. The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms [Internet]. Health Technol Assess [cited 2017 Sep 11]Dec;20(94): Available from: Systematic Reviews Unclear Comparator 14. Esposito F, Angileri FF, Kruse P, Cavallo LM, Solari D, Esposito V, et al. Fibrin sealants in dura sealing: a systematic literature review. PLoS ONE. 2016;11(4):e Available from: PubMed: PM Wang Z, Xiao L, Guo H, Zhao G, Ma J. The efficiency and safety of fibrin sealant for reducing blood loss in primary total hip arthroplasty: A systematic review and metaanalysis. Int J Surg Jan;37:50-7. PubMed: PM Li J, Li HB, Zhai XC, Qin L, Jiang XQ, Zhang ZH. Topical use of topical fibrin sealant can reduce the need for transfusion, total blood loss and the volume of drainage in total knee and hip arthroplasty: A systematic review and meta-analysis of 1489 patients. Int J Surg Dec;36(Pt A): PubMed: PM Rogers AC, Turley LP, Cross KS, McMonagle MP. Meta-analysis of the use of surgical sealants for suture-hole bleeding in arterial anastomoses. Br J Surg Dec;103(13): PubMed: PM Li ZJ, Fu X, Tian P, Liu WX, Li YM, Zheng YF, et al. Fibrin sealant before wound closure in total knee arthroplasty reduced blood loss: a meta-analysis. Knee Surg Sports Traumatol Arthrosc Jul;23(7): PubMed: PM Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, et al. Tissue adhesives for closure of surgical incisions [Internet]. Cochrane Database Sys Rev Nov [cited 2017 Sep 11] 11. Available from: Liu J, Cao JG, Wang L, Ma XL. Effect of fibrin sealant on blood loss following total knee arthroplasty: a systematic review and meta-analysis. Int J Surg. 2014;12(2): PubMed: PM SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 8

9 21. Orci LA, Oldani G, Berney T, Andres A, Mentha G, Morel P, et al. Systematic review and meta-analysis of fibrin sealants for patients undergoing pancreatic resection. HPB (Oxford) Jan;16(1):3-11. Available from: PubMed: PM Wang H, Shan L, Zeng H, Sun M, Hua Y, Cai Z. Is fibrin sealant effective and safe in total knee arthroplasty? A meta-analysis of randomized trials. J Orthop Surg Res May 16;9:36. Available from: PubMed: PM Weldrick C, Bashar K, O'Sullivan TA, Gillis E, Clarke MM, Tang TY, et al. A comparison of fibrin sealant versus standard closure in the reduction of postoperative morbidity after groin dissection: a systematic review and meta-analysis. Eur J Surg Oncol Nov;40(11): PubMed: PM Unclear Intervention 24. Al-Mubarak L, Al-Haddab M. Cutaneous wound closure materials: an overview and update. J Cutan Aesthet Surg Oct;6(4): Available from: PubMed: PM Clinical Practice Guidelines Uncertain Methodology 25. Marshall G. Skin glues for wound closure [Internet]. Aust Prescr [cited 2017 Sep 11]36(2):49-5. Available from: Gov.UK. Sprayable fibrin sealants (Evicel, Tisseel and Artiss): updated guidance [Internet]. London (UK): Government of the United Kingdom, Medicines and Healthcare Products Regulatory Agency; 2013 Feb [cited 2017 Sept 11]. Available from: Review Articles 27. Kollar D, Huszar T, Poharnok Z, Cselovszky E, Olah A. A review of techniques for closure of the pancreatic remnant following distal pancreatectomy. Dig Surg. 2016;33(4): PubMed: PM Regula CG, Yag-Howard C. Suture products and techniques: what to use, where, and why. Dermatol Surg Oct;41 Suppl 10:S187-S200. PubMed: PM Sanders L, Nagatomi J. Clinical applications of surgical adhesives and sealants [Internet]. Crit Rev Biomed Eng [cited 2017 Sep 11]42(3-4): Available from: 7b4e html SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 9

10 30. Shah NV, Meislin R. Current state and use of biological adhesives in orthopedic surgery. Orthopedics Dec;36(12): Available from: Additional References 31. Clinical and economic evidence supporting the value of Dermabond Prineo skin closure system (22cm) in hip and knee arthroplasty [Internet]. Raynham (MA): DePuy Synthes; 2016 [cited 2017 Sep 11] (Value Analysis Brief). Available from: a/product%20support%20materials/technique%20guides/prineo%20vab%20final %20Copy%20Approved.pdf SUMMARY OF ABSTRACTS The Use of Medical Glue to Close Surgical Wounds 10