Raw data of study; Raw data of Comparison Between NEOSORB Plus and NEOSORB. (XLSX 39 kb

Bum Tae (5489840)

Chang Jeong (5489843)

Cheol Kwak (474070)

Hyeon Kim (3799771)

Ja Ku (5489846)

Ju Park (3511490)

Jung Kim (455846)

BMC Surgery

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Additional file 1: of Comparison of intraoperative handling and wound healing between (NEOSORBÂŽ plus) and coated polyglactin 910 suture (NEOSORBÂŽ): 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 80years, 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 11days after surgery. Cumulative skin infection, seroma, and suture sinus events within 30days 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.This work was supported by Supporting Project to Test New Domestic Medical Devices in Hospitals funded by Ministry of Health and Welfare (MOHW), Korea Health Industry Development Institute (KHIDI) and Samyang Biopharmaceuticals Corp. No competing financial conflicts exist for any of
the authors

Tae, Bum Sik

Park, Ju Hyun

Kim, Jung Kwon

Ku, Ja Hyeon

Kwak, Cheol

Kim, Hyeon Hoe

Jeong, Chang Wook

SNU Open Repository and Archive

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

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

Additional file 1: of Comparison of intraoperative handling and wound healing between (NEOSORBÂŽ plus) and coated polyglactin 910 suture (NEOSORBÂŽ): a prospective, single-blind, randomized controlled trial

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