Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2015-05-31
2015-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NEOSORB PLUS
Subjects who are treated by NEOSORB PLUS
NEOSORB PLUS
Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)
NEOSORB
Subjects who are treated by NEOSORB
NEOSORB
Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
Interventions
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NEOSORB PLUS
Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)
NEOSORB
Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clean and clean-contaminated surgery
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Medical Research Collaborating Center, Seoul, Korea
OTHER
Korea Health Industry Development Institute
OTHER_GOV
Samyang Biopharmaceuticals Corporation
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Chang Wook Jeong
Professor
Principal Investigators
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Chang Wook Jeong, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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D-1503-016-653
Identifier Type: -
Identifier Source: org_study_id
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