This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Information provided by:
Dallas VA Medical Center Identifier:
First received: July 13, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 identifier: NCT00938691

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ponciano Cruz, MD, Chair, Division of Dermatology Identifier: NCT00938691     History of Changes
Other Study ID Numbers: ASDS-45322
Study First Received: July 13, 2009
Last Updated: July 13, 2009

Keywords provided by Dallas VA Medical Center:

Additional relevant MeSH terms:
Pathologic Processes processed this record on August 22, 2017