Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts

Wound Closure Techniques Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550574
• Other study ID #: 773443
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: June 19, 2017
• Start date: August 2015
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Closure Techniques

Intervention

Procedure:
• Wound Closure with 2-octylcyanoacrylate

• Wound Closure with 5-0 Vicryl Sutures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Graft Failure on Case Report	The secondary endpoint will include incidence of graft failure (partial and complete on both sides).	3 months
Secondary	Incidence of Complications on Case Report	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.	3 months