Undermining During Cutaneous Wound Closure

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

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Key information

Conditions

Wound Closure Techniques

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wound Closure with Undermining

Procedure

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

Procedure

One side of the wound will remain un-undermined.

Primary outcomes

Assessment of Scar on the Patient and Observer Scar Assessment Scale

Time frame: 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 outcomes

Measurement of Scar Width

Time frame: 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.
Assessment of Complications

Time frame: 3 months

Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Nov 13, 2014
Registry last updated: Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed