Use of 5-0 Prolene Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure

Wound Closure Techniques Clinical Trial

Official title:

Use of 5-0 Prolene Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02991755
• Other study ID #: 811023
• Status: Active, not recruiting
• Phase: N/A
• First received: December 2, 2016
• Last updated: August 17, 2017
• Start date: October 2015
• Est. completion date: September 2019

Study information

• Verified date: August 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 5-0 prolene during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut (both SOC).

Description:

The purpose of this study is to determine whether the use of 5-0 prolene during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut (both SOC). The investigators will use a split wound model, where half of the wound is treated with 5-0 prolene 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 (research procedure). The scar width and adverse events will be recorded.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 2019
• Est. primary completion date: April 2016
• 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

• 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 5-0 prolene vs 5-0 fast absorbing gut

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	Sum of Observer components of Patient Observer Scar Assessment Scale	POSAS Sum	up to 4 months after enrollment
Secondary	Sum of Patient components of Patient Observer Scar Assessment Scale	Patient POSAS Sum	up to 4 months after enrollment
Secondary	Sum of complications for each intervention side	Sum of Complications	up to 4 months after enrollment