Comparison Between NEOSORB Plus and NEOSORB

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

Official Title
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Comparison of Intraoperative Handling and Wound Healing Between NEOSORB Plus Antibacterial Suture With NEOSORB Suture: Prospective, Single-blind, Randomized Controlled Trial

Conditions
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Skin Reaction to Suture Material

Intervention / Treatment
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* Device: NEOSORB PLUS
* Device: NEOSORB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEOSORB PLUS<br>Subjects who are treated by NEOSORB PLUS | Device: NEOSORB PLUS<br>* Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)<br>* Other names: Antibacterial suture material;|
| Active Comparator: NEOSORB<br>Subjects who are treated by NEOSORB | Device: NEOSORB<br>* Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)<br>* Other names: Non-antibacterial suture material;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall handling | 1 to 5 scale | During the operation | 

Secondary Outcome Measures

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