Safety and efficacy of triclosan-coated polyglactin 910 suture in prevention of surgical site infection in postpartum women : A randomized controlled trial
Journal Title: Journal of the Indian Medical Association - Year 2018, Vol 116, Issue 11
Abstract
The objective of present study was to compare the safety and efficacy of two triclosan-coated polyglactin 910 sutures, MITSU AB and VICRYL Plus, in postpartum women. This was a prospective, multicenter, single-blinded, randomized controlled trial conducted at two clinical settings in India. Between February 2017 to July 2017, a total of 122 women were enrolled and randomly assigned (1:1) to either MITSU AB or VICRYL Plus (N=61 women in each arm) before surgical incision closure during episiotomy or caesarean section. All women were followed at 14 days, 30 days, and 6 months after the surgery. The safety endpoint was overall wound dehiscence recorded at each follow-up (FU). Efficacy endpoints were surgical site infection (SSI) rate at each FU and length of hospital stay. The suturing was performed at abdominal, uterine, vaginal and perennial areas and was significantly balanced in both arms. None of the women reported wound dehiscence nor reported SSI in both arms. The length of hospital stay did not differ significantly between MITSU AB and VICRYL Plus arms (3.25 ± 0.62 days versus 3.37 ± 1.57 days; p=0.58). There was no incidence of an adverse event or serious adverse event up to 6 months. The results of the study showed comparable safety and efficacy of the MITSU AB to VICRYL Plus suture in women requiring surgical closure during episiotomy or caesarean section. The study is registered at the clinical trial registry of India (CTRI/2017/01/007736).
Authors and Affiliations
Asha Dixit, Purnima Nadkarni, Ashok Thakkar
Keywords
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