Comparison Between NEOSORB Plus and NEOSORB

Seoul National University Hospital100 enrolled

Overview

This study is to investigate whether NEOSORB Plus antibacterial suture (chlorhexidine diacetate coated PGLA910) is not inferior to NEOSORB suture (PGLA910) in the points of intraoperative handling.

1. Enrollment 1. Urologic surgery which needs fascia and subcutaneous tissue repairs 2. Clean and clean-contaminated surgery 3. Patients aged more than 18 years and under 80 years 2. Randomization 1. NEOSORB Plus (chlorhexidine diacetate coated PGLA910) or NEOSORB (PGLA910) suture 2. Stratification by operative methods: Open surgery vs. laparoscopic or robot-assisted laparoscopic surgery 3. Follow-up with 30 days 1. Primary endpoint: intraoperative handling during operation 2. Secondary endpoint: wound healing assessment on postoperative 1st (+1) days and 11th (± 4) days 3. Safety evaluation: counting adverse events within postoperative 30 days

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Skin Reaction to Suture Material

Interventions

NEOSORB PLUSDEVICE

Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)

NEOSORBDEVICE

Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Urologic surgery which needs fascia and subcutaneous tissue repairs * Clean and clean-contaminated surgery Exclusion Criteria: * Contaminated surgery * Wound requiring retention suture * Suspicious malnutrition status * Active infection status or AIDS * Incision sites prone to expand, stretch, distend, or require support * Allergy or hypersensitivity to chlorhexidine diacetate * Significant active medical illness which in the opinion of the investigator would preclude protocol treatment

Locations (1)

Seoul National University Hospital

Seoul, South Korea