Overview

This trial is active, not recruiting.

Condition cicatrix
Treatments intradermal suture
Sponsor Dallas VA Medical Center
Start date April 2009
End date June 2010
Trial size 25 participants
Trial identifier NCT00938691, ASDS-45322

Summary

Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads to significant widening of the final scar. Historically, the only way to combat this tension was to support the deeper portion of the wound with sutures that dissolve over several weeks. However, scars take many months to fully develop their greatest strength. So even with the standard technique, wounds in areas of high tension still show spreading of the scar with time. The investigators believe that these wounds require an extended duration of support throughout the scar's maturation period. Until recently, there did not exist a suture that could provide this long duration of support without also carrying the risk of the body rejecting it. Recently, a new extremely long acting absorbable biomaterial has been FDA approved for use as a suture. The investigators plan to use this suture to test the theory that alleviating stress on high tension wounds throughout the period which they gain their maximal integrity produces less scar spread and ultimately better cosmetic outcomes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
intradermal suture
(Active Comparator)
intradermal suture

Primary Outcomes

Measure
Scar spread
time frame: 3 months and 1 year

Secondary Outcomes

Measure
Scar appearance
time frame: 3 months and 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients requiring excision of a lesion on chest, back, or shoulders Exclusion Criteria: - History of ionizing radiation - History of keloid or hypertrophic scarring - History of or current internal malignancy - History of bleeding disorder - History of collagen or elastin disorder - Current use of immunosuppressive medications

Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Dallas VA Medical Center.