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Optimal Suture Choice for Improved Scar Outcomes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Dallas VA Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938691
First Posted: July 14, 2009
Last Update Posted: July 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dallas VA Medical Center
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Dallas VA Medical Center:

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

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

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: July 13, 2009
First Posted: July 14, 2009
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