Comparison Between NEOSORB Plus and NEOSORB

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Skin Reaction to Suture Material

Treatments: Device: NEOSORB; Device: NEOSORB PLUS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02431039

D-1503-016-653

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

NEOSORB PLUS

Experimental group

Description:

Subjects who are treated by NEOSORB PLUS

Treatment:

Device: NEOSORB PLUS

NEOSORB

Active Comparator group

Description:

Subjects who are treated by NEOSORB

Treatment:

Device: NEOSORB