Dermal Suturing Only Versus Layered Cutaneous Closure

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.

Detailed Description
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The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. Our aims are to compare outcomes using a split wound model, where half the wound is sutured with one technique and the other half is sutured with the other. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wounds with a single layer closure will result in cosmetically superior wound outcomes.

Official Title
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Dermal Suturing Only Versus Layered Cutaneous Closure: A Randomized Split Wound Comparative Effectiveness Trial

Conditions
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Wound Closure Techniques

Intervention / Treatment
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* Procedure: Dermal Suturing Only Wound Closure
* Procedure: Layered Cutaneous Wound Closure


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 unable to be fully closed via primary closure

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: Dermal Suturing Only Wound Closure<br>The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion. | Procedure: Dermal Suturing Only Wound Closure<br>* The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion.<br>Procedure: Layered Cutaneous Wound Closure<br>* The side assigned to layered closure is closed with 5-0 fast acting gut.<br>|
| Active Comparator: Layered Cutaneous Wound Closure<br>The side assigned to layered closure is closed with 5-0 fast acting gut. | Procedure: Dermal Suturing Only Wound Closure<br>* The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion.<br>Procedure: Layered Cutaneous Wound Closure<br>* The side assigned to layered closure is closed with 5-0 fast acting gut.<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 at 3 Months | After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques. | 3 months | 
| Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months | After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 12 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques. | 12 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 and 12 months | 
| Assessment of Complications | Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures. | 3 months and 12 months |