Overview

This trial is active, not recruiting.

Condition wound closure techniques
Treatments wound closure with 2-octylcyanoacrylate, wound closure with 5-0 fast absorbing gut sutures
Sponsor University of California, Davis
Start date July 2015
End date October 2015
Trial size 50 participants
Trial identifier NCT02547077, 774875

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
One side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent).
wound closure with 2-octylcyanoacrylate
wound closure with 5-0 fast absorbing gut sutures
(Active Comparator)
One side of the patient's wound defect will be assigned to wound closure with 5-0 fast absorbing gut sutures.
wound closure with 2-octylcyanoacrylate
wound closure with 5-0 fast absorbing gut sutures

Primary Outcomes

Measure
Assessment of Scar on the Patient and Observer Scar Assessment Scale
time frame: 3 months

Secondary Outcomes

Measure
Measurement of Scar Width
time frame: 3 months
Assessment of Complications
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Daniel Eisen, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of California, Davis.