- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00938691
Optimal Suture Choice for Improved Scar Outcomes
July 13, 2009 updated by: Dallas VA Medical Center
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75216
- Dallas VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tepha
|
|
Active Comparator: Vicryl
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Scar spread
Time Frame: 3 months and 1 year
|
3 months and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Scar appearance
Time Frame: 3 months and 1 year
|
3 months and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kevin F Kia, MD, Dermatology, UT-Southwestern
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Anticipated)
June 1, 2010
Study Completion (Anticipated)
July 1, 2010
Study Registration Dates
First Submitted
July 13, 2009
First Submitted That Met QC Criteria
July 13, 2009
First Posted (Estimate)
July 14, 2009
Study Record Updates
Last Update Posted (Estimate)
July 14, 2009
Last Update Submitted That Met QC Criteria
July 13, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASDS-45322
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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