Overview

This trial is active, not recruiting.

Condition wound closure techniques
Treatments dermal suturing only wound closure, layered cutaneous wound closure
Sponsor University of California, Davis
Start date July 2014
End date April 2015
Trial size 50 participants
Trial identifier NCT02383186, 614521

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
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.
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
The side assigned to layered closure is closed with 5-0 fast acting gut.
(Active Comparator)
The side assigned to layered closure is closed with 5-0 fast acting gut.
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
The side assigned to layered closure is closed with 5-0 fast acting gut.

Primary Outcomes

Measure
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months
time frame: 3 months
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months
time frame: 12 months

Secondary Outcomes

Measure
Measurement of Scar Width
time frame: 3 months and 12 months
Assessment of Complications
time frame: 3 months and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Dermal Suturing Only Versus Layered Cutaneous Closure: A Randomized Split Wound Comparative Effectiveness Trial
Principal investigator Daniel Eisen, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of California, Davis.