Optimal Suture Choice for Improved Scar Outcomes
Primary Purpose
Cicatrix
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intradermal Suture
Intradermal Suture
Sponsored by
About this trial
This is an interventional prevention trial for Cicatrix focused on measuring Scar, Appearance, Spread
Eligibility 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
Sites / Locations
- Dallas VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tepha
Vicryl
Arm Description
Outcomes
Primary Outcome Measures
Scar spread
Secondary Outcome Measures
Scar appearance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00938691
Brief Title
Optimal Suture Choice for Improved Scar Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Dallas VA Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix
Keywords
Scar, Appearance, Spread
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tepha
Arm Type
Experimental
Arm Title
Vicryl
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Intradermal Suture
Intervention Type
Procedure
Intervention Name(s)
Intradermal Suture
Primary Outcome Measure Information:
Title
Scar spread
Time Frame
3 months and 1 year
Secondary Outcome Measure Information:
Title
Scar appearance
Time Frame
3 months and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin F Kia, MD
Organizational Affiliation
Dermatology, UT-Southwestern
Official's Role
Study Director
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23752288
Citation
Kia KF, Burns MV, Vandergriff T, Weitzul S. Prevention of scar spread on trunk excisions: a rater-blinded randomized controlled trial. JAMA Dermatol. 2013 Jun;149(6):687-91. doi: 10.1001/jamadermatol.2013.3004.
Results Reference
derived
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Optimal Suture Choice for Improved Scar Outcomes
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