Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts

NCT ID: NCT02550574

Last Updated: 2017-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-05-31

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.

Conditions

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Wound Closure Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Wound Closure with 2-octylcyanoacrylate

Intervention Type PROCEDURE

Wound Closure with 5-0 Vicryl Sutures

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Wound Closure with 2-octylcyanoacrylate

Intervention Type PROCEDURE

Wound Closure with 5-0 Vicryl Sutures

Intervention Type PROCEDURE

Interventions

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Wound Closure with 2-octylcyanoacrylate

Intervention Type PROCEDURE

Wound Closure with 5-0 Vicryl Sutures

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Eisen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Other Identifiers

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773443

Identifier Type: -

Identifier Source: org_study_id

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