Undermining During Cutaneous Wound Closure

Study Overview
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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.

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.

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

Conditions
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Wound Closure Techniques

Intervention / Treatment
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* Procedure: Wound Closure with Undermining
* Procedure: Wound Closure without Undermining


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wound Closure with Undermining<br>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<br>* 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.<br>Procedure: Wound Closure without Undermining<br>* One side of the wound will remain un-undermined.<br>|
| Active Comparator: Wound Closure without Undermining<br>One side of the wound will remain un-undermined. | Procedure: Wound Closure with Undermining<br>* 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.<br>Procedure: Wound Closure without Undermining<br>* One side of the wound will remain un-undermined.<br>|

What is the study measuring?
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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 |