Skip to content

Dermal Suturing Only Versus Layered Cutaneous Closure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02383186
Enrollment
50
Registered
2015-03-09
Start date
2014-05-28
Completion date
2016-04-30
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Closure Techniques

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.

Interventions

PROCEDUREDermal 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.

PROCEDURELayered Cutaneous Wound Closure

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

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months3 monthsAfter 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 Months12 monthsAfter 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

MeasureTime frameDescription
Measurement of Scar Width3 months and 12 monthsThe 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 Complications3 months and 12 monthsNoting the presence or absence of bleeding, dehiscence, infection or spitting sutures.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026