Dermal Suturing Only Versus Layered Cutaneous Closure

Wound Closure Techniques Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383186
• Other study ID #: 614521
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: July 17, 2017
• Start date: May 28, 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Closure Techniques

Intervention

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.
• Layered Cutaneous Wound Closure
The side assigned to layered closure is closed with 5-0 fast acting gut.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Assessment of Complications	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.	3 months and 12 months

External Links

•   University of California-Davis Department of Dermatology Clinical Research