Dermal Suturing Only Versus Layered Cutaneous Closure

Not Applicable

Completed

• Conditions: Wound Closure Techniques
• Interventions: Procedure: Dermal Suturing Only Wound Closure; Procedure: Layered Cutaneous Wound Closure

• Registration Number: NCT02383186
• Lead Sponsor: University of California, Davis

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-05-28
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermal Suturing Only Wound Closure	Layered Cutaneous Wound Closure	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.
Layered Cutaneous Wound Closure	Dermal Suturing Only Wound Closure	The side assigned to layered closure is closed with 5-0 fast acting gut.
Dermal Suturing Only Wound Closure	Dermal Suturing Only Wound Closure	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.
Layered Cutaneous Wound Closure	Layered Cutaneous Wound Closure	The side assigned to layered closure is closed with 5-0 fast acting gut.

Primary Outcome Measures

Name	Time	Method
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months	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.
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of Scar Width	3 months and 12 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	3 months and 12 months	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.