Comparison Between NEOSORB Plus and NEOSORB

Phase 2

Completed

• Conditions: Skin Reaction to Suture Material
• Interventions: Device: NEOSORB; Device: NEOSORB PLUS

• Registration Number: NCT02431039
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2015-04-26
• Study First Submitted QC: 2015-04-26
• Study First Posted: 2015-04-30
• Study Start: 2015-05
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Urologic surgery which needs fascia and subcutaneous tissue repairs
• Clean and clean-contaminated surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NEOSORB	NEOSORB	Subjects who are treated by NEOSORB
NEOSORB PLUS	NEOSORB PLUS	Subjects who are treated by NEOSORB PLUS

Primary Outcome Measures

Name	Time	Method
Overall handling	During the operation	1 to 5 scale

Secondary Outcome Measures

Name	Time	Method
Edema	On postoperative 1st(+1) and 11th(±4) day	0, + (slight increase in firmness), ++(skin dimples with pressure), +++ (tense firmness)
Skin temperative increase	On postoperative 1st(+1) and 11th(±4) day	0, + (slight), ++(definite), +++ (hot, radiating)
30 days cumulative seroma requiring drainage rate	Within postoperative 30 days	No vs. YES
Adverse events	Within postoperative 30 days
Pain	On postoperative 1st(+1) and 11th(±4) day	0, + (with pressure), ++(with touching), +++ (constant)
30 days cumulative skin infection rate	Within postoperative 30 days	No vs. YES
30 days cumulative suture sinus (culture-negative) rate	Within postoperative 30 days	No vs. YES
Knot security	During the operation	1 to 5 scale
Infection	On postoperative 1st(+1) and 11th(±4) day	No vs. YES
Suture sinus, culture-negative	On postoperative 1st and 11(± 4)th day	No vs. YES
Erythema	On postoperative 1st(+1) and 11th(±4) day	0, + (closure line redness), ++(redness\<2mm), +++ (redness\>2mm)
First-throw knot holding	During the operation	1 to 5 scale
Surgical hand	During the operation	1 to 5 scale
Lack of fraying	During the operation	1 to 5 scale
Knot tie-down smoothness	During the operation	1 to 5 scale
Memory	During the operation	1 to 5 scale
Healing progress, apposition	On postoperative 1st(+1) and 11th(±4) day	Complete vs. Incomplete
Ease of passage though tissue	During the operation	1 to 5 scale
Seroma requiring drainage	On postoperative 1st(+1) and 11th(±4) day	No vs. YES

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of