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Optimal Suture Choice for Improved Scar Outcomes

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ClinicalTrials.gov Identifier: NCT00938691
Recruitment Status : Unknown
Verified July 2009 by Dallas VA Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2009
Last Update Posted : July 14, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cicatrix Procedure: Intradermal Suture Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : April 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tepha Procedure: Intradermal Suture
Active Comparator: Vicryl Procedure: Intradermal Suture



Primary Outcome Measures :
  1. Scar spread [ Time Frame: 3 months and 1 year ]

Secondary Outcome Measures :
  1. Scar appearance [ Time Frame: 3 months and 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938691


Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
Investigators
Study Director: Kevin F Kia, MD Dermatology, UT-Southwestern

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ponciano Cruz, MD, Chair, Division of Dermatology
ClinicalTrials.gov Identifier: NCT00938691     History of Changes
Other Study ID Numbers: ASDS-45322
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009

Keywords provided by Dallas VA Medical Center:
Scar
Appearance
Spread

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes