Evaluation of safety and efficacy of polyglactin 910 suture in surgical incision closure: clinical study protocol for a randomized controlled trial
Background: Surgical site infection (SSI) occurs in a considerable portion of patients after closure of surgical incision. The newer synthetic absorbable sutures consistently display proven advantages for wound healing over naturally derived suture. The study is planned to evaluate the safety and efficacy of MITSU™ Polyglactin 910 Suture with Coated Vicryl® Polyglactin 910 Suture in a closure of surgical incision.
Methods: This is a prospective, multicentric, post-marketing, randomized, controlled, single-blinded, comparative study in a closure of surgical incision where general soft tissue approximation and/or ligation is required during an elective surgery. Patients are randomized to 1:1 ratio in the test (MITSU Polyglactin 910 Suture) and reference (Coated Vicryl Polyglactin 910 Suture) groups. Patients are monitored for safety and efficacy outcomes, viz. the rate of SSI, hospital length of stay, overall wound dehiscence and any adverse events/serious adverse events at post-procedural, 14 days, 30 days and 6 months of surgery. The rate of SSI for each group will be analyzed using one sided T-test. The effect of type of suture on SSI and overall wound dehiscence will be evaluated with chi-square test. Length of stay in hospital will be evaluated with student’s t-test.
Conclusions: The study has been designed to compare the safety and efficacy of MITSU Polyglactin 910 Suture versus Coated Vicryl Polyglactin 910 Suture in a closure of surgical incision.
Trial registration: The trial protocol has been registered with the clinical trial registry of India (CTRI/2017/01/007717; registered on 17/01/2017).
World Health Organization, Global guidelines for the prevention of surgical site infection. World Health Organization, 2016.
Valecha SM, Saswade MN. An original research paper on incidence and risk factors for surgical site infections following major abdominal surgeries in obstetrics and gynaecology. Int J Reprod Contracept Obstetr Gynecol. 2017;6(5):1859-63.
Shah S, Singhal T, Naik R. A 4-year prospective study to determine the incidence and microbial etiology of surgical site infections at a private tertiary care hospital in Mumbai, India. Am J Infection Control. 2015;43(1):59-62.
Ramasubramanian V, Iyer V, Sewlikar S, Desa A. Epidemiology of healthcare acquired infection–An Indian perspective on surgical site infection and catheter related blood stream infection. Indian J Basic Applied Med Res. 2014;3:46-63.
Hoshino S, Yoshida Y, Tanimura S, Yamauchi Y, Noritomi T, Yamashita Y. A study of the efficacy of antibacterial sutures for surgical site infection: a retrospective controlled trial. Int Surg. 2013;98(2):129-32.
Jung KH, Oh SJ, Choi KK, Kim SM, Choi MG, Lee JH, et al., Effect of triclosan-coated sutures on surgical site infection after gastric cancer surgery via midline laparotomy. Ann Surg Treatment Res. 2014;87(6):311-8.
Negi V, Pal S, Juyal D, Sharma MK, Sharma N. Bacteriological profile of surgical site infections and their antibiogram: A study from resource constrained rural setting of Uttarakhand State, India. J Clin Diagnos Res. 2015;9(10):DC17.
Greenberg JA, Clark RM. Advances in suture material for obstetric and gynecologic surgery. Reviews Obstetr Gynecol. 2009;2(3):146.
Kundra R, Newman S, Saithna A, Lewis AC, Srinivasan S, Srinivasan K. Absorbable or non-absorbable sutures? A prospective, randomised evaluation of aesthetic outcomes in patients undergoing elective day-case hand and wrist surgery. Ann R Coll Surg Engl. 2010;92(8):665-7.
Guyuron B, Vaughan C. A comparison of absorbable and nonabsorbable suture materials for skin repair. Plastic Reconst Surg. 1992;89(2):234-6.
Mingmalairak C, Ungbhakorn P, Paocharoen V. Efficacy of antimicrobial coating suture coated polyglactin 910 with tricosan (Vicryl plus) compared with polyglactin 910 (Vicryl) in reduced surgical site infection of appendicitis, double blind randomized control trial, preliminary safety report. Med J Med Assoc Thailand, 2009;92(6):770.
Galal I, El-Hindawy K. Impact of using triclosan-antibacterial sutures on incidence of surgical site infection. Am J Surg. 2011;202(2):133-8.
Justinger C, Moussavian MR, Schlueter C, Kopp B, Kollmar O, Schilling MK. Antibiotic coating of abdominal closure sutures and wound infection. Surgery. 2009;145(3):330-4.
Chen SY, Chen TM, Dai NT, Fu JP, Chang SC, Deng SC, et al. Do antibacterial-coated sutures reduce wound infection in head and neck cancer reconstruction? Eur J Surg Oncol (EJSO), 2011;37(4):300-4.
Mingmalairak C. Antimicrobial sutures: new strategy in surgical site infections. Science against Microbial Pathogens: Communicating Current Research and Technological Advances: Formatex Research Center. 2011: 313-323.
Sandy‐Hodgetts K, Carville K, Leslie GD. Determining risk factors for surgical wound dehiscence: a literature review. Int Wound J. 2015;12(3):265-75.
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Am J Infection Control. 1999;27(2):97-134.
Katz S, Izhar M, Mirelman D. Bacterial adherence to surgical sutures. A possible factor in suture induced infection. Ann Surg. 1981;194(1):35.
Pillai CKS, Sharma CP. Absorbable polymeric surgical sutures: chemistry, production, properties, biodegradability, and performance. J Biomaterials App. 2010;25(4):291-366.
Nakamura T, Sato T, Takayama Y, Naito M, Yamanashi T, Miura H, et al. Risk factors for surgical site infection after laparoscopic surgery for colon cancer. Surgical infections. 2016;17(4):454-8.
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). Surgical Infections. 2005;6(3):313-21.
Fleck T. Triclosan-coated sutures for the reduction of sternal wound infections: economic considerations. Ann Thoracic Surg. 2007;84(1):232-6.
McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999;23(12):1210-4.