Back to resultsEversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
Primary Purpose
Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Everted suture technique
Non-everted suture technique
Sponsored by
About this trial
This is an interventional supportive care trial for Basal Cell Carcinoma
Eligibility Criteria
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
Sites / Locations
- UC Davis, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Everted suture technique
Non-everted suture technique
Arm Description
Technique that everts the skin; the edges will sit up against each other in a little peak, raised above the surrounding skin.
Surgical wound will be approximated such that the suture line is flat relative to the surrounding skin.
Outcomes
Primary Outcome Measures
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.
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.
Scar measurements (height, width, length)
Scar volume will be measured in centimeters on both sides of the wound
Scar induration
Scar induration area will be measured in centimeters for both sides of the wound
Scar erythema
Scar erythema area will be measured in centimeters for both sides of the wound
Wound contour irregularities
Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement
Stand cone volume
The volume of standing cones will be measured via length, width and height measurements in centimeters
Uneven edge measurement
The area of uneven edges will be measured via a length x height measurement in centimeters
Hyperpigmentation area
areas of hyperpigmentation will be measured via a length x width measurement in centimeters
Secondary Outcome Measures
Infection
Infections occurring anytime during the study period will be recorded
wound dehiscence
incidence of wound infection will be recorded anytime during the study period
spitting sutures
spitting sutures will be counted for each side of the wound at 3 and 6 months
Full Information
NCT ID
NCT01770002
First Posted
January 15, 2013
Last Updated
April 15, 2015
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01770002
Brief Title
Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
Official Title
Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Everted suture technique
Arm Type
Active Comparator
Arm Description
Technique that everts the skin; the edges will sit up against each other in a little peak, raised above the surrounding skin.
Arm Title
Non-everted suture technique
Arm Type
Active Comparator
Arm Description
Surgical wound will be approximated such that the suture line is flat relative to the surrounding skin.
Intervention Type
Procedure
Intervention Name(s)
Everted suture technique
Intervention Type
Procedure
Intervention Name(s)
Non-everted suture technique
Primary Outcome Measure Information:
Title
Everted versus non-everted suturing techniques
Description
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.
Time Frame
3 and 6 months
Title
Mean score of sum of 2 blinded observers POSAS scores
Description
The mean summed total of two blinded reviewers Physician Observer Scar Assessment Scale (POSAS) scores for each side of the wound.
Time Frame
3 and 6 months
Title
Scar measurements (height, width, length)
Description
Scar volume will be measured in centimeters on both sides of the wound
Time Frame
3 and 6 months
Title
Scar induration
Description
Scar induration area will be measured in centimeters for both sides of the wound
Time Frame
3 and 6 months
Title
Scar erythema
Description
Scar erythema area will be measured in centimeters for both sides of the wound
Time Frame
3 and 6 months
Title
Wound contour irregularities
Description
Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement
Time Frame
3 and 6 months
Title
Stand cone volume
Description
The volume of standing cones will be measured via length, width and height measurements in centimeters
Time Frame
3 and 6 months
Title
Uneven edge measurement
Description
The area of uneven edges will be measured via a length x height measurement in centimeters
Time Frame
3 and 6 months
Title
Hyperpigmentation area
Description
areas of hyperpigmentation will be measured via a length x width measurement in centimeters
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Infection
Description
Infections occurring anytime during the study period will be recorded
Time Frame
up to 6 months
Title
wound dehiscence
Description
incidence of wound infection will be recorded anytime during the study period
Time Frame
up to 6 months
Title
spitting sutures
Description
spitting sutures will be counted for each side of the wound at 3 and 6 months
Time Frame
3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research
Learn more about this trial
Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
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