Undermining During Cutaneous Wound Closure

Not Applicable

Completed

• Conditions: Wound Closure Techniques
• Interventions: Procedure: Wound Closure with Undermining; Procedure: Wound Closure without Undermining

• Registration Number: NCT02289859
• Lead Sponsor: University of California, Davis

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-13
• Primary Completion: 2016-04
• Study Completion: 2016-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound Closure without Undermining	Wound Closure with Undermining	One side of the wound will remain un-undermined.
Wound Closure with Undermining	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	Wound Closure without Undermining	One side of the wound will remain un-undermined.
Wound Closure with Undermining	Wound Closure without 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.

Primary Outcome Measures

Name	Time	Method
Assessment of Scar on the Patient and Observer Scar Assessment Scale	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of Complications	3 months	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
Measurement of Scar Width	3 months	The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.