Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure

Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial

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.

Study Overview

• Status: Completed
• Conditions: Wound Closure Techniques
• Intervention / Treatment: Procedure: Wound Closure with 2-octylcyanoacrylate; Procedure: Wound Closure with 5-0 Fast Absorbing Gut Sutures

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wound Closure with 2-octylcyanoacrylate; One side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent).	Procedure: Wound Closure with 2-octylcyanoacrylate; Procedure: Wound Closure with 5-0 Fast Absorbing Gut Sutures
Active Comparator: Wound Closure with 5-0 Fast Absorbing Gut; One side of the patient's wound defect will be assigned to wound closure with 5-0 fast absorbing gut sutures.	Procedure: Wound Closure with 2-octylcyanoacrylate; Procedure: Wound Closure with 5-0 Fast Absorbing Gut Sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
Assessment of Complications	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.	3 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 774875