Overview

This trial is active, not recruiting.

Condition wound closure techniques
Treatments wound closure with undermining, wound closure without undermining
Sponsor University of California, Davis
Start date July 2014
End date April 2015
Trial size 50 participants
Trial identifier NCT02289859, 613430

Summary

The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
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.
wound closure with undermining
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.
wound closure without undermining
One side of the wound will remain un-undermined.
(Active Comparator)
One side of the wound will remain un-undermined.
wound closure with undermining
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.
wound closure without undermining
One side of the wound will remain un-undermined.

Primary Outcomes

Measure
Assessment of Scar on the Patient and Observer Scar Assessment Scale
time frame: 3 months

Secondary Outcomes

Measure
Measurement of Scar Width
time frame: 3 months
Assessment of Complications
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Able to give informed consent themselves - Patient scheduled for cutaneous surgical procedure with predicted linear closure - Willing to return for follow up visits Exclusion Criteria: - 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

Additional Information

Official title Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial
Principal investigator Daniel Eisen, M.D.
Description The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining will result in cosmetically superior wound outcomes.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of California, Davis.