Optimal Suture Choice for Improved Scar Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Dallas VA Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT00938691
First received: July 13, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 13, 2009
July 13, 2009
April 2009
June 2010   (final data collection date for primary outcome measure)
Scar spread [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Scar appearance [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Optimal Suture Choice for Improved Scar Outcomes
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Cicatrix
Procedure: Intradermal Suture
  • Experimental: Tepha
    Intervention: Procedure: Intradermal Suture
  • Active Comparator: Vicryl
    Intervention: Procedure: Intradermal Suture
Kia KF, Burns MV, Vandergriff T, Weitzul S. Prevention of scar spread on trunk excisions: a rater-blinded randomized controlled trial. JAMA Dermatol. 2013 Jun;149(6):687-91. doi: 10.1001/jamadermatol.2013.3004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
July 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00938691
ASDS-45322
Yes
Ponciano Cruz, MD, Chair, Division of Dermatology
Dallas VA Medical Center
Not Provided
Study Director: Kevin F Kia, MD Dermatology, UT-Southwestern
Dallas VA Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP