Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts
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 Vicryl Sutures
Sponsored by
About this trial
This is an interventional supportive care trial for Wound Closure Techniques
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted closure with full-thickness skin graft
- 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
- Patients on systemic steroid therapies
- Patients with Marfans
- Patients with allergies to 2-octylcyanoacrylate
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 vicryl sutures
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 vicryl sutures.
Outcomes
Primary Outcome Measures
Appearance 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 vicryl sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Secondary Outcome Measures
Incidence of Graft Failure on Case Report
The secondary endpoint will include incidence of graft failure (partial and complete on both sides).
Incidence of Complications on Case Report
Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
Full Information
NCT ID
NCT02550574
First Posted
September 9, 2015
Last Updated
June 19, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02550574
Brief Title
Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts
Official Title
Use of 2-octylcyanoacrylate (Dermabond) During Cutaneous Wound Closure With Full-thickness Skin Grafts: a Randomized Split Wound Comparative Effectiveness Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (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 cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures.
Detailed Description
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures. Our aims are to compare outcomes using a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with sutures, per the standard of care. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. Our hypothesis is that 2-octylcyanoacrylate will result in cosmetically superior wound outcomes.
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 (Anticipated)
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 vicryl sutures
Arm Type
Active Comparator
Arm Description
One side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures.
Intervention Type
Procedure
Intervention Name(s)
Wound Closure with 2-octylcyanoacrylate
Intervention Type
Procedure
Intervention Name(s)
Wound Closure with 5-0 Vicryl Sutures
Primary Outcome Measure Information:
Title
Appearance 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 vicryl 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
Incidence of Graft Failure on Case Report
Description
The secondary endpoint will include incidence of graft failure (partial and complete on both sides).
Time Frame
3 months
Title
Incidence of Complications on Case Report
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:
Over 18 years of age
Able to give informed consent themselves
Patient scheduled for cutaneous surgical procedure with predicted closure with full-thickness skin graft
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
Patients on systemic steroid therapies
Patients with Marfans
Patients with allergies to 2-octylcyanoacrylate
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
Learn more about this trial
Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts
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