Optimal Suture Choice for Improved Scar Outcomes
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cicatrix |
Procedure: Intradermal Suture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
- Scar spread [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
- Scar appearance [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tepha | Procedure: Intradermal Suture |
| Active Comparator: Vicryl | Procedure: Intradermal Suture |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Ponciano Cruz, MD, Chair, Division of Dermatology |
| ClinicalTrials.gov Identifier: | NCT00938691 History of Changes |
| Other Study ID Numbers: | ASDS-45322 |
| Study First Received: | July 13, 2009 |
| Last Updated: | July 13, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Dallas VA Medical Center:
|
Scar Appearance Spread |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013