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

Not Applicable

Completed

• Conditions: Wound Closure Techniques
• Interventions: Procedure: Wound Closure with 2-octylcyanoacrylate; Procedure: Wound Closure with 5-0 Fast Absorbing Gut Sutures

• Registration Number: NCT02547077
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-11
• Primary Completion: 2015-12
• Study Completion: 2016-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound Closure with 2-octylcyanoacrylate	Wound Closure with 5-0 Fast Absorbing Gut Sutures	One 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	Wound Closure with 5-0 Fast Absorbing Gut Sutures	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 2-octylcyanoacrylate	One 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	Wound Closure with 2-octylcyanoacrylate	One side of the patient's wound defect will be assigned to wound closure with 5-0 fast absorbing gut sutures.

Primary Outcome Measures

Name	Time	Method
Assessment of Scar on the Patient and Observer Scar Assessment Scale	3 months	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

Name	Time	Method
Assessment of Complications	3 months	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
Measurement of Scar Width	3 months	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.