Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 30, 2017
May 1, 2017
5 months
September 9, 2015
May 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (2)
Measurement of Scar Width
3 months
Assessment of Complications
3 months
Study Arms (2)
Wound Closure with 2-octylcyanoacrylate
EXPERIMENTALOne side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent).
Wound Closure with 5-0 Fast Absorbing Gut
ACTIVE COMPARATOROne side of the patient's wound defect will be assigned to wound closure with 5-0 fast absorbing gut sutures.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31403536DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Eisen, M.D.
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 11, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2015
Study Completion
May 1, 2016
Last Updated
May 30, 2017
Record last verified: 2017-05