Comparison of intraoperative handling and wound healing between (NEOSORB® plus) and coated polyglactin 910 suture (NEOSORB®): a prospective, single-blind, randomized controlled trial.

BACKGROUND

Coated polyglactin 910 suture with chlorhexidine (NEOSORB® Plus) has recently been developed to imbue the parent suture with antibacterial activity against organisms that commonly cause surgical site infections (SSI). This prospective, single-blinded, randomized trial, was performed to compare the intraoperative handling and wound healing characteristics of NEOSORB® Plus with those of the traditional polyglactin 910 suture (NEOSORB®) in urologic surgery patients.

METHODS

Patients (aged 19 to 80 years, n = 100) were randomized in a 1:1 ratio for treatment with either NEOSORB® Plus or NEOSORB®, and stratified into an open surgery or a minimally invasive surgery group. The primary endpoint was the assessment of overall intraoperative handling of the sutures. Secondary endpoints included specific intraoperative handling measures and wound healing characteristics. Wound healing was assessed at one and 11 days after surgery. Cumulative skin infection, seroma, and suture sinus events within 30 days after surgery were also evaluated.

RESULTS

A total of 96 patients were included, with 47 patients in the NEOSORB® Plus group and 49 patients in the NEOSORB® group. Scores for intraoperative handling were favorable and were not significantly different between the two suture groups. Wound healing characteristics were also comparable. The incidence of adverse events was 13.6%, although none were deemed attributable to the suture, and no difference was observed between the two groups.

CONCLUSIONS

NEOSORB® Plus is not inferior to traditional sutures in terms of intraoperative handling and wound healing, potentially making NEOSORB® Plus a beneficial alternative for patients at increased risk of SSI.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT02431039 . Trial registration date 14 August 2015.