Optimal Suture Choice for Improved Scar Outcomes

Not Applicable

• Conditions: Cicatrix
• Interventions: Procedure: Intradermal Suture

• Registration Number: NCT00938691
• Lead Sponsor: Dallas VA Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Status Verified: 2009-07
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Last Update Submitted: 2009-07-13
• Study First Posted: 2009-07-14
• Last Update Posted: 2009-07-14
• Primary Completion: 2010-06
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vicryl	Intradermal Suture	-
Tepha	Intradermal Suture	-

Primary Outcome Measures

Name	Time	Method
Scar spread	3 months and 1 year

Secondary Outcome Measures

Name	Time	Method
Scar appearance	3 months and 1 year

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States