Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

April 15, 2015 updated by: University of California, Davis
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
3 and 6 months
Mean score of sum of 2 blinded observers POSAS scores
Time Frame: 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.
3 and 6 months
Scar measurements (height, width, length)
Time Frame: 3 and 6 months
Scar volume will be measured in centimeters on both sides of the wound
3 and 6 months
Scar induration
Time Frame: 3 and 6 months
Scar induration area will be measured in centimeters for both sides of the wound
3 and 6 months
Scar erythema
Time Frame: 3 and 6 months
Scar erythema area will be measured in centimeters for both sides of the wound
3 and 6 months
Wound contour irregularities
Time Frame: 3 and 6 months
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
Time Frame: 3 and 6 months
The volume of standing cones will be measured via length, width and height measurements in centimeters
3 and 6 months
Uneven edge measurement
Time Frame: 3 and 6 months
The area of uneven edges will be measured via a length x height measurement in centimeters
3 and 6 months
Hyperpigmentation area
Time Frame: 3 and 6 months
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
Time Frame: up to 6 months
Infections occurring anytime during the study period will be recorded
up to 6 months
wound dehiscence
Time Frame: up to 6 months
incidence of wound infection will be recorded anytime during the study period
up to 6 months
spitting sutures
Time Frame: 3 and 6 months
spitting sutures will be counted for each side of the wound at 3 and 6 months
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 265161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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