Undermining During Cutaneous Wound Closure

Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial

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

Study Overview

• Status: Completed
• Conditions: Wound Closure Techniques
• Intervention / Treatment: Procedure: Wound Closure with Undermining; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Procedure: Wound Closure without Undermining; One side of the wound will remain un-undermined.
Active Comparator: Wound Closure without Undermining; One side of the wound will remain un-undermined.	Procedure: 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.; Procedure: Wound Closure without Undermining; One side of the wound will remain un-undermined.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Scar Width	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.	3 months
Assessment of Complications	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.	3 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General Publications

• 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.

Helpful Links

• University of California-Davis Department of Dermatology Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 613430