Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure
Primary Purpose
Wound Closure Techniques
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wound Closure with 2-octylcyanoacrylate
Wound Closure with 5-0 Fast Absorbing Gut Sutures
Sponsored by
About this trial
This is an interventional supportive care trial for Wound Closure Techniques
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted linear closure of 3 cm of longer.
- Willing to return for follow-up visits
Exclusion Criteria:
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Pregnant Women
- Wounds with predicted closure length less than 3 cm
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wound Closure with 2-octylcyanoacrylate
Wound Closure with 5-0 Fast Absorbing Gut
Arm Description
One side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent).
One side of the patient's wound defect will be assigned to wound closure with 5-0 fast absorbing gut sutures.
Outcomes
Primary Outcome Measures
Assessment of Scar on the Patient and Observer Scar Assessment Scale
After surgical procedure, half of the subject's wound will be with 2-octylcyanoacrylate, while the other half is closed 5-0 fast absorbing gut sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Secondary Outcome Measures
Measurement of Scar Width
The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.
Assessment of Complications
Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
Full Information
NCT ID
NCT02547077
First Posted
September 9, 2015
Last Updated
May 24, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02547077
Brief Title
Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure
Official Title
Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut.
Detailed Description
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigators will use a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Closure Techniques
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wound Closure with 2-octylcyanoacrylate
Arm Type
Experimental
Arm Description
One side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent).
Arm Title
Wound Closure with 5-0 Fast Absorbing Gut
Arm Type
Active Comparator
Arm Description
One side of the patient's wound defect will be assigned to wound closure with 5-0 fast absorbing gut sutures.
Intervention Type
Procedure
Intervention Name(s)
Wound Closure with 2-octylcyanoacrylate
Intervention Type
Procedure
Intervention Name(s)
Wound Closure with 5-0 Fast Absorbing Gut Sutures
Primary Outcome Measure Information:
Title
Assessment of Scar on the Patient and Observer Scar Assessment Scale
Description
After surgical procedure, half of the subject's wound will be with 2-octylcyanoacrylate, while the other half is closed 5-0 fast absorbing gut sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Measurement of Scar Width
Description
The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.
Time Frame
3 months
Title
Assessment of Complications
Description
Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Able to give informed consent themselves
Patient scheduled for cutaneous surgical procedure with predicted linear closure of 3 cm of longer.
Willing to return for follow-up visits
Exclusion Criteria:
Mentally handicapped
Unable to understand written and oral English
Incarceration
Under 18 years of age
Pregnant Women
Wounds with predicted closure length less than 3 cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
31403536
Citation
Zhuang AR, Beroukhim K, Armstrong AW, Sivamani RK, Eisen DB. Comparison of 2-Octylcyanoacrylate Versus 5-0 Fast-Absorbing Gut During Linear Wound Closures and the Effect on Wound Cosmesis. Dermatol Surg. 2020 May;46(5):628-634. doi: 10.1097/DSS.0000000000002076.
Results Reference
derived
Learn more about this trial
Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure
We'll reach out to this number within 24 hrs