Undermining During Cutaneous Wound Closure

Wound Closure Techniques Clinical Trial

Official title:

Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289859
• Other study ID #: 613430
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: July 17, 2017
• Start date: May 2014
• Est. completion date: July 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 undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.

Description:

The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining will result in cosmetically superior wound outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 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 with diameter > 3 cm

• Wounds unable to be fully closed without undermining

Related Conditions & MeSH terms

• Wound Closure Techniques
• Wounds and Injuries

Intervention

Procedure:
• Wound Closure with Undermining
The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
• Wound Closure without Undermining
One side of the wound will remain un-undermined.

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	After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.	3 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
Secondary	Assessment of Complications	Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.	3 months

External Links

•   University of California-Davis Department of Dermatology Clinical Research