Dermal Suturing Only Versus Layered Cutaneous Closure
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Typical duration for not_applicable
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
May 28, 2014
CompletedFirst Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJuly 18, 2017
July 1, 2017
1.8 years
November 10, 2014
July 17, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months
After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
3 months
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months
After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 12 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
12 months
Secondary Outcomes (2)
Measurement of Scar Width
3 months and 12 months
Assessment of Complications
3 months and 12 months
Study Arms (2)
Dermal Suturing Only Wound Closure
ACTIVE COMPARATORThe side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion.
Layered Cutaneous Wound Closure
ACTIVE COMPARATORThe side assigned to layered closure is closed with 5-0 fast acting gut.
Interventions
The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion.
The side assigned to layered closure is closed with 5-0 fast acting gut.
Eligibility Criteria
You may qualify if:
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted linear closure
- Willing to return for follow up visits
You may not qualify if:
- Mentally handicapped
- Incarceration
- Pregnant Women
- Wounds with predicted closure length less than 3 cm
- Wounds unable to be fully closed via primary closure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Eisen, M.D.
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2014
First Posted
March 9, 2015
Study Start
May 28, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
July 18, 2017
Record last verified: 2017-07