Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts

Not Applicable

Completed

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

• Registration Number: NCT02550574
• 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-15
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2017-05
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

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

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

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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

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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 Vicryl Sutures	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 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 vicryl sutures	Wound Closure with 5-0 Vicryl Sutures	One side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures.
Wound closure with 5-0 vicryl sutures	Wound Closure with 2-octylcyanoacrylate	One side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures.

Primary Outcome Measures

Name	Time	Method
Appearance 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 vicryl 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
Incidence of Graft Failure on Case Report	3 months	The secondary endpoint will include incidence of graft failure (partial and complete on both sides).
Incidence of Complications on Case Report	3 months	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.