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

Bum Sik Tae, Ju Hyun Park, Jung Kwon Kim, Ja Hyeon Ku, Cheol Kwak, Hyeon Hoe Kim, Chang Wook Jeong, Bum Sik Tae, Ju Hyun Park, Jung Kwon Kim, Ja Hyeon Ku, Cheol Kwak, Hyeon Hoe Kim, Chang Wook Jeong

Abstract

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.

Keywords: Chlorhexidine acetate; Intraoperative handling; Polyglactin 910 suture; Surgical site infection.

Conflict of interest statement

Ethics approval and consent to participate

Seoul National University Hospital Institutional Review Board approved this trial (D-1503-016-653). Written informed consents were obtained from all participants before trial screening.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT participant flow diagram
Fig. 2
Fig. 2
Intraoperative handling. Ninety-six patients (NP = 47, N = 49) completed the study and were included in the final analysis. The primary endpoint of overall intraoperative handling is shown in the first set of bars. Secondary endpoints for individual aspects of intraoperative handling comprise the remaining bars. Values for good, fair, and poor handling were small and were combined into one measurement. NP, NEOSORB® Plus; N, NEOSORB®
Fig. 3
Fig. 3
Patients stratified by surgery type. NP, NEOSORB® Plus; N, NEOSORB®
Fig. 4
Fig. 4
This non-inferiority threshold is the maximum allowable excess of outcome events arising from the Neosorb® Plus compared to the Neosorb®

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