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
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Dallas VA Medical Center

Additional 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
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

ClinicalTrials.gov processed this record on October 30, 2014