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| Name | Class |
|---|---|
| Medical Research Collaborating Center, Seoul, Korea | OTHER |
| Korea Health Industry Development Institute | OTHER_GOV |
| Samyang Biopharmaceuticals Corporation | INDUSTRY |
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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.
Enrollment
Randomization
Follow-up with 30 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEOSORB PLUS | Experimental | Subjects who are treated by NEOSORB PLUS |
|
| NEOSORB | Active Comparator | Subjects who are treated by NEOSORB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEOSORB PLUS | Device | Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall handling | 1 to 5 scale | During the operation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang Wook Jeong, M.D.,Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29980202 | Derived | Tae BS, Park JH, Kim JK, Ku JH, Kwak C, Kim HH, Jeong CW. Comparison of intraoperative handling and wound healing between (NEOSORB(R) plus) and coated polyglactin 910 suture (NEOSORB(R)): a prospective, single-blind, randomized controlled trial. BMC Surg. 2018 Jul 6;18(1):45. doi: 10.1186/s12893-018-0377-4. |
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| NEOSORB | Device | Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910) |
|
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| 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 |