Dermal Suturing Only Versus Layered Cutaneous Closure

University of California, Davis50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Wound Closure Techniques

Interventions

Dermal Suturing Only Wound ClosurePROCEDURE

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 ClosurePROCEDURE

The side assigned to layered closure is closed with 5-0 fast acting gut.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 3 months and 12 months

Assessment of Complications

Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.

Time frame: 3 months and 12 months

Data from ClinicalTrials.gov

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