Dermal Suturing Only Versus Layered Cut… | Clinical Trial

Key information

Conditions

Wound Closure Techniques

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermal Suturing Only Wound Closure

Procedure

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

Procedure

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

Primary outcomes

Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months

Time frame: 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.
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months

Time frame: 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.

Secondary outcomes

Measurement of Scar Width

Time frame: 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

Time frame: 3 months and 12 months

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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Mar 9, 2015
Registry last updated: Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed