Comparison Between NEOSORB Plus and NEOSORB
Comparison of Intraoperative Handling and Wound Healing Between NEOSORB Plus Antibacterial Suture With NEOSORB Suture: Prospective, Single-blind, Randomized Controlled Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2015
CompletedFirst Posted
Study publicly available on registry
April 30, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedAugust 14, 2015
August 1, 2015
3 months
April 26, 2015
August 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Overall handling
1 to 5 scale
During the operation
Secondary Outcomes (19)
Ease of passage though tissue
During the operation
First-throw knot holding
During the operation
Knot tie-down smoothness
During the operation
Knot security
During the operation
Surgical hand
During the operation
- +14 more secondary outcomes
Study Arms (2)
NEOSORB PLUS
EXPERIMENTALSubjects who are treated by NEOSORB PLUS
NEOSORB
ACTIVE COMPARATORSubjects who are treated by NEOSORB
Interventions
Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)
Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
Eligibility Criteria
You may qualify if:
- Urologic surgery which needs fascia and subcutaneous tissue repairs
- Clean and clean-contaminated surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 29980202DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Chang Wook Jeong, M.D.,Ph.D.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 26, 2015
First Posted
April 30, 2015
Study Start
May 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
August 14, 2015
Record last verified: 2015-08