Evaluation of safety and efficacy of polyglactin 910 suture in surgical incision closure: clinical study protocol for a randomized controlled trial

ABSTRACT

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 11 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).