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

Abstract

<p class="abstract"><strong>Background:</strong> <span lang="EN-IN">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<sup>®</sup> Polyglactin 910 Suture in a closure of surgical incision. </span></p><p class="abstract"><strong>Methods:</strong> <span lang="EN-IN">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.</span></p><p class="abstract"><strong>Conclusions:</strong> <span lang="EN-IN">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. </span></p><p class="keywords"><strong><span lang="EN-IN">Trial registration</span></strong><span lang="EN-IN">: The trial protocol has been registered with the clinical trial registry of India (CTRI/2017/01/007717; registered on 17/01/2017).</span></p>

Bacterial accumulation on different types of suturing materials in periodontal surgery and implantology – literature review.

“…Polyglactin 910 (Vicryl) consists of a copolymer of 90% glycolide and 10% l-lactide 63 . It is a resorbable, multifilament synthetic material, and its resorption occurs by hydrolysis 64 .…”

Fabrication of Tannic Acid coated Polyglactin Surgical Suture to Prevent Bacterial Infection

“…The absorbable suture unrequired any revision surgery to remove the suture since the suture is absorbed into the body made this type of suture more likely to use (Baghel, et al, 2015). The use of absorbable sutures gives some advantages such as minimizing clinical time and patient anxiety toward post-operative procedures and also giving a better aesthetic appearance rather than non-absorbable sutures (Dixit et al, 2018).…”

“…4, Mount 2022: pp xx-xx adjuvant systemic therapy (De Simone et al, 2020). The material and types of sutures used in surgical procedures contribute to the occurrence of SSI (Dixit et al, 2018). The monofilament suture is made of single strand materials therefore it served a small microbial contact area and reduce the possibility of bacterial growth (Xu et al, 2022).…”

“…(De Simone et al, 2020). Administration of antibiotics as prophylaxis could lead to prolonged and irrational use of antibiotics, thus antibacterial sutures could be an alternative to prevent SSI (De Simone et al, 2020;Dixit et al, 2018). Sutures coating with antibiotics is one of the techniques which could reduce the possibility of bacterial colonization in braided sutures (Dhom et al, 2017).…”