Skin Reaction to Suture Material
Conditions
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
Interventions
DEVICENEOSORB PLUS
Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)
DEVICENEOSORB
Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
Sponsors
Medical Research Collaborating Center, Seoul, Korea
Korea Health Industry Development Institute
Samyang Biopharmaceuticals Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall handling | During the operation | 1 to 5 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First-throw knot holding | During the operation | 1 to 5 scale |
| Knot tie-down smoothness | During the operation | 1 to 5 scale |
| Knot security | During the operation | 1 to 5 scale |
| Surgical hand | During the operation | 1 to 5 scale |
| Memory | During the operation | 1 to 5 scale |
| Lack of fraying | During the operation | 1 to 5 scale |
| Healing progress, apposition | On postoperative 1st(+1) and 11th(±4) day | Complete vs. Incomplete |
| Infection | On postoperative 1st(+1) and 11th(±4) day | No vs. YES |
| Seroma requiring drainage | On postoperative 1st(+1) and 11th(±4) day | No vs. YES |
| Ease of passage though tissue | During the operation | 1 to 5 scale |
| Erythema | On postoperative 1st(+1) and 11th(±4) day | 0, + (closure line redness), ++(redness\<2mm), +++ (redness\>2mm) |
| Edema | On postoperative 1st(+1) and 11th(±4) day | 0, + (slight increase in firmness), ++(skin dimples with pressure), +++ (tense firmness) |
| Pain | On postoperative 1st(+1) and 11th(±4) day | 0, + (with pressure), ++(with touching), +++ (constant) |
| Skin temperative increase | On postoperative 1st(+1) and 11th(±4) day | 0, + (slight), ++(definite), +++ (hot, radiating) |
| 30 days cumulative skin infection rate | Within postoperative 30 days | No vs. YES |
| 30 days cumulative seroma requiring drainage rate | Within postoperative 30 days | No vs. YES |
| 30 days cumulative suture sinus (culture-negative) rate | Within postoperative 30 days | No vs. YES |
| Adverse events | Within postoperative 30 days | — |
| Suture sinus, culture-negative | On postoperative 1st and 11(± 4)th day | No vs. YES |
Countries
South Korea
Outcome results
None listed