Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures
1 other identifier
observational
10
1 country
1
Brief Summary
The purpose of this study is to compare the cosmetic outcome between buried intradermal and superficial cutaneous suture closures versus buried intradermal sutureand superficial Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following elliptical excision of benign or malignant lesions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2013
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
September 5, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedApril 15, 2016
September 1, 2013
7 months
September 5, 2013
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall scar appearance as evaluated by the Patient and Observer Scar Assessment Scale
6 months
Secondary Outcomes (2)
Rates of postoperative complications
6 months
Time for closure of each split half portion of wound
1 hour (intraoperative)
Study Arms (1)
Surgical excision
Interventions
Eligibility Criteria
Outpatient dermatology clinic
You may qualify if:
- years or greater in age
- Simple excision of benign or malignant lesion on the back
- Final scar length of at least 3cm
You may not qualify if:
- Known history of keloid formation or hypertrophic scars
- Known adhesive allergy
- Pregnancy or active breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Dermatology Clinic
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cosmetic Dermatology, Vice-Chair of Operations
Study Record Dates
First Submitted
September 5, 2013
First Posted
September 10, 2013
Study Start
November 1, 2013
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
April 15, 2016
Record last verified: 2013-09