Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

Not Applicable

Completed

• Conditions: Basal Cell Carcinoma; Melanoma; Squamous Cell Carcinoma
• Interventions: Procedure: Everted suture technique; Procedure: Non-everted suture technique

• Registration Number: NCT01770002
• Lead Sponsor: University of California, Davis

Brief Summary

The investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2013-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Over 18 years of age
• Able to give informed consent themselves
• Willing to return for follow up visits

Exclusion Criteria

• Mentally handicapped
• Unable to understand written and oral English
• Incarceration
• Under 18 years of age
• Unwilling to return for follow up
• Pregnant Women
• Wounds less than 3 cm in length

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everted suture technique	Everted suture technique	Technique that everts the skin; the edges will sit up against each other in a little peak, raised above the surrounding skin.
Non-everted suture technique	Non-everted suture technique	Surgical wound will be approximated such that the suture line is flat relative to the surrounding skin.

Primary Outcome Measures

Name	Time	Method
Everted versus non-everted suturing techniques	3 and 6 months	Primary outcome measures for this study are the post operative scar width measured at 1 cm from the midline on both sides of the scar.
Mean score of sum of 2 blinded observers POSAS scores	3 and 6 months	The mean summed total of two blinded reviewers Physician Observer Scar Assessment Scale (POSAS) scores for each side of the wound.
Scar measurements (height, width, length)	3 and 6 months	Scar volume will be measured in centimeters on both sides of the wound
Scar induration	3 and 6 months	Scar induration area will be measured in centimeters for both sides of the wound
Scar erythema	3 and 6 months	Scar erythema area will be measured in centimeters for both sides of the wound
Wound contour irregularities	3 and 6 months	Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement
Stand cone volume	3 and 6 months	The volume of standing cones will be measured via length, width and height measurements in centimeters
Uneven edge measurement	3 and 6 months	The area of uneven edges will be measured via a length x height measurement in centimeters
Hyperpigmentation area	3 and 6 months	areas of hyperpigmentation will be measured via a length x width measurement in centimeters

Secondary Outcome Measures

Name	Time	Method
Infection	up to 6 months	Infections occurring anytime during the study period will be recorded
wound dehiscence	up to 6 months	incidence of wound infection will be recorded anytime during the study period
spitting sutures	3 and 6 months	spitting sutures will be counted for each side of the wound at 3 and 6 months

Trial Locations

Locations (1)

UC Davis, Department of Dermatology; 🇺🇸 Sacramento, California, United States