Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

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

Study Overview

• Status: Completed
• Conditions: Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma
• Intervention / Treatment: Procedure: Everted suture technique; Procedure: Non-everted suture technique

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: Everted suture technique
ACTIVE_COMPARATOR: Non-everted suture technique; Surgical wound will be approximated such that the suture line is flat relative to the surrounding skin.	Procedure: Non-everted suture technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Everted versus non-everted suturing techniques	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.	3 and 6 months
Mean score of sum of 2 blinded observers POSAS scores	The mean summed total of two blinded reviewers Physician Observer Scar Assessment Scale (POSAS) scores for each side of the wound.	3 and 6 months
Scar measurements (height, width, length)	Scar volume will be measured in centimeters on both sides of the wound	3 and 6 months
Scar induration	Scar induration area will be measured in centimeters for both sides of the wound	3 and 6 months
Scar erythema	Scar erythema area will be measured in centimeters for both sides of the wound	3 and 6 months
Wound contour irregularities	Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement	3 and 6 months
Stand cone volume	The volume of standing cones will be measured via length, width and height measurements in centimeters	3 and 6 months
Uneven edge measurement	The area of uneven edges will be measured via a length x height measurement in centimeters	3 and 6 months
Hyperpigmentation area	areas of hyperpigmentation will be measured via a length x width measurement in centimeters	3 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

Helpful Links

• University of California-Davis Department of Dermatology Clinical Research

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: January 15, 2013
• First Submitted That Met QC Criteria: January 15, 2013
• First Posted (ESTIMATE): January 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 16, 2015
• Last Update Submitted That Met QC Criteria: April 15, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: 265161