Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of 2-octylcyanoacrylate (Dermabond) During Cutaneous Wound Closure With Full-thickness Skin Grafts: a Randomized Split Wound Comparative Effectiveness Trial

Conditions
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Wound Closure Techniques

Intervention / Treatment
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* Procedure: Wound Closure with 2-octylcyanoacrylate
* Procedure: Wound Closure with 5-0 Vicryl Sutures


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wound closure with 2-octylcyanoacrylate<br>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<br> <br> Procedure: Wound Closure with 5-0 Vicryl Sutures<br> <br> |
| Active Comparator: Wound closure with 5-0 vicryl sutures<br>One side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures. | Procedure: Wound Closure with 2-octylcyanoacrylate<br> <br> Procedure: Wound Closure with 5-0 Vicryl Sutures<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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