Undermining During Cutaneous Wound Closure
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.
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 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 18, 2017
July 1, 2017
1.9 years
November 10, 2014
July 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of Scar on the Patient and Observer Scar Assessment Scale
After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
3 months
Secondary Outcomes (2)
Measurement of Scar Width
3 months
Assessment of Complications
3 months
Study Arms (2)
Wound Closure with Undermining
ACTIVE COMPARATORThe side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
Wound Closure without Undermining
ACTIVE COMPARATOROne side of the wound will remain un-undermined.
Interventions
The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
One side of the wound will remain un-undermined.
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 with diameter \> 3 cm
- Wounds unable to be fully closed without undermining
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Joo J, Pourang A, Tchanque-Fossuo CN, Armstrong AW, Tartar DM, King TH, Sivamani RK, Eisen DB. Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial. Arch Dermatol Res. 2022 Sep;314(7):697-703. doi: 10.1007/s00403-021-02280-5. Epub 2021 Sep 21.
PMID: 34546436DERIVED
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
November 13, 2014
Study Start
May 1, 2014
Primary Completion
April 1, 2016
Study Completion
July 1, 2016
Last Updated
July 18, 2017
Record last verified: 2017-07