Dermal Suturing Only Versus Layered Cutaneous Closure

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

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

Study Overview

• Status: Completed
• Conditions: Wound Closure Techniques
• Intervention / Treatment: Procedure: Dermal Suturing Only Wound Closure; Procedure: Layered Cutaneous Wound 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Procedure: Layered Cutaneous Wound Closure; The side assigned to layered closure is closed with 5-0 fast acting gut.
Active Comparator: Layered Cutaneous Wound Closure; The side assigned to layered closure is closed with 5-0 fast acting gut.	Procedure: 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.; Procedure: Layered Cutaneous Wound Closure; The side assigned to layered closure is closed with 5-0 fast acting gut.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

Helpful Links

• University of California-Davis Department of Dermatology Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 9, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 614521