Optimal Suture Choice for Improved Scar Outcomes
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 13, 2009
CompletedFirst Posted
Study publicly available on registry
July 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 14, 2009
July 1, 2009
1.2 years
July 13, 2009
July 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scar spread
3 months and 1 year
Secondary Outcomes (1)
Scar appearance
3 months and 1 year
Study Arms (2)
Tepha
EXPERIMENTALVicryl
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients requiring excision of a lesion on chest, back, or shoulders
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Related Publications (1)
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.
PMID: 23752288DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kevin F Kia, MD
Dermatology, UT-Southwestern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
July 13, 2009
First Posted
July 14, 2009
Study Start
April 1, 2009
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
July 14, 2009
Record last verified: 2009-07