Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure

Wound Closure Techniques Clinical Trial

Official title:

Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547077
• Other study ID #: 774875
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: May 24, 2017
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2017
• 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 linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut.

Description:

The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigators will use a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Able to give informed consent themselves

• Patient scheduled for cutaneous surgical procedure with predicted linear closure of 3 cm of longer.

• 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

• Wounds with predicted closure length less than 3 cm

Related Conditions & MeSH terms

• Wound Closure Techniques
• Wounds and Injuries

Intervention

Procedure:
• Wound Closure with 2-octylcyanoacrylate

• Wound Closure with 5-0 Fast Absorbing Gut 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	Assessment 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 fast absorbing gut sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.	3 months
Secondary	Measurement of Scar Width	The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.	3 months
Secondary	Assessment of Complications	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.	3 months