NCT02550574

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 21, 2017

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

September 9, 2015

Last Update Submit

June 19, 2017

Conditions

Wound Closure Techniques

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Incidence of Graft Failure on Case Report

    3 months

  • Incidence of Complications on Case Report

    3 months

Study Arms (2)

Wound closure with 2-octylcyanoacrylate

EXPERIMENTAL

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-octylcyanoacrylateProcedure: Wound Closure with 5-0 Vicryl Sutures

Wound closure with 5-0 vicryl sutures

ACTIVE COMPARATOR

One side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures.

Procedure: Wound Closure with 2-octylcyanoacrylateProcedure: Wound Closure with 5-0 Vicryl Sutures

Interventions

Wound Closure with 2-octylcyanoacrylatePROCEDURE
Wound closure with 2-octylcyanoacrylateWound closure with 5-0 vicryl sutures
Wound Closure with 5-0 Vicryl SuturesPROCEDURE
Wound closure with 2-octylcyanoacrylateWound closure with 5-0 vicryl sutures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

octyl 2-cyanoacrylate

Study Officials

  • Daniel Eisen, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 15, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

June 21, 2017

Record last verified: 2016-12