Dermal Suturing Only Versus Layered Cutaneous Closure

Not Applicable

Completed

• Conditions: Wound Closure Techniques

• 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.

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.