Undermining During Cutaneous Wound Closure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Wound Closure Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Wound Closure with Undermining

Intervention Type 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

Intervention Type PROCEDURE

One side of the wound will remain un-undermined.

Wound Closure without Undermining

One side of the wound will remain un-undermined.

Group Type ACTIVE_COMPARATOR

Wound Closure with Undermining

Intervention Type 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

Intervention Type PROCEDURE

One side of the wound will remain un-undermined.

Interventions

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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.

Intervention Type PROCEDURE

Wound Closure without Undermining

One side of the wound will remain un-undermined.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No