- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02431039
Comparison Between NEOSORB Plus and NEOSORB
August 12, 2015 updated by: Chang Wook Jeong, Seoul National University Hospital
Comparison of Intraoperative Handling and Wound Healing Between NEOSORB Plus Antibacterial Suture With NEOSORB Suture: Prospective, Single-blind, Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NEOSORB PLUS
Subjects who are treated by NEOSORB PLUS
|
Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)
Other Names:
|
Active Comparator: NEOSORB
Subjects who are treated by NEOSORB
|
Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall handling
Time Frame: During the operation
|
1 to 5 scale
|
During the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ease of passage though tissue
Time Frame: During the operation
|
1 to 5 scale
|
During the operation
|
First-throw knot holding
Time Frame: During the operation
|
1 to 5 scale
|
During the operation
|
Knot tie-down smoothness
Time Frame: During the operation
|
1 to 5 scale
|
During the operation
|
Knot security
Time Frame: During the operation
|
1 to 5 scale
|
During the operation
|
Surgical hand
Time Frame: During the operation
|
1 to 5 scale
|
During the operation
|
Memory
Time Frame: During the operation
|
1 to 5 scale
|
During the operation
|
Lack of fraying
Time Frame: During the operation
|
1 to 5 scale
|
During the operation
|
Healing progress, apposition
Time Frame: On postoperative 1st(+1) and 11th(±4) day
|
Complete vs. Incomplete
|
On postoperative 1st(+1) and 11th(±4) day
|
Infection
Time Frame: On postoperative 1st(+1) and 11th(±4) day
|
No vs. YES
|
On postoperative 1st(+1) and 11th(±4) day
|
Seroma requiring drainage
Time Frame: On postoperative 1st(+1) and 11th(±4) day
|
No vs. YES
|
On postoperative 1st(+1) and 11th(±4) day
|
Suture sinus, culture-negative
Time Frame: On postoperative 1st and 11(± 4)th day
|
No vs. YES
|
On postoperative 1st and 11(± 4)th day
|
Erythema
Time Frame: On postoperative 1st(+1) and 11th(±4) day
|
0, + (closure line redness), ++(redness<2mm), +++ (redness>2mm)
|
On postoperative 1st(+1) and 11th(±4) day
|
Edema
Time Frame: On postoperative 1st(+1) and 11th(±4) day
|
0, + (slight increase in firmness), ++(skin dimples with pressure), +++ (tense firmness)
|
On postoperative 1st(+1) and 11th(±4) day
|
Pain
Time Frame: On postoperative 1st(+1) and 11th(±4) day
|
0, + (with pressure), ++(with touching), +++ (constant)
|
On postoperative 1st(+1) and 11th(±4) day
|
Skin temperative increase
Time Frame: On postoperative 1st(+1) and 11th(±4) day
|
0, + (slight), ++(definite), +++ (hot, radiating)
|
On postoperative 1st(+1) and 11th(±4) day
|
30 days cumulative skin infection rate
Time Frame: Within postoperative 30 days
|
No vs. YES
|
Within postoperative 30 days
|
30 days cumulative seroma requiring drainage rate
Time Frame: Within postoperative 30 days
|
No vs. YES
|
Within postoperative 30 days
|
30 days cumulative suture sinus (culture-negative) rate
Time Frame: Within postoperative 30 days
|
No vs. YES
|
Within postoperative 30 days
|
Adverse events
Time Frame: Within postoperative 30 days
|
Within postoperative 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chang Wook Jeong, M.D.,Ph.D., Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
April 26, 2015
First Submitted That Met QC Criteria
April 26, 2015
First Posted (Estimate)
April 30, 2015
Study Record Updates
Last Update Posted (Estimate)
August 14, 2015
Last Update Submitted That Met QC Criteria
August 12, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-1503-016-653
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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