Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Daniel Eisen, MD, University of California, Davis

ClinicalTrials.gov Identifier:

NCT01770002

First received: January 15, 2013

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Purpose

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

Condition	Intervention
Basal Cell Carcinoma Squamous Cell Carcinoma Melanoma	Procedure: Everted suture technique Procedure: Non-everted suture technique

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

Resource links provided by NLM:

MedlinePlus related topics: Cosmetics Melanoma Scars

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Everted versus non-everted suturing techniques [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
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) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Scar volume will be measured in centimeters on both sides of the wound
Scar induration [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Scar induration area will be measured in centimeters for both sides of the wound
Scar erythema [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Scar erythema area will be measured in centimeters for both sides of the wound
Wound contour irregularities [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement
Stand cone volume [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
The volume of standing cones will be measured via length, width and height measurements in centimeters
Uneven edge measurement [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
The area of uneven edges will be measured via a length x height measurement in centimeters
Hyperpigmentation area [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
areas of hyperpigmentation will be measured via a length x width measurement in centimeters

Secondary Outcome Measures:

Infection [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
Infections occurring anytime during the study period will be recorded
wound dehiscence [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
incidence of wound infection will be recorded anytime during the study period
spitting sutures [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
spitting sutures will be counted for each side of the wound at 3 and 6 months

Estimated Enrollment:	50
Study Start Date:	January 2012
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770002

Locations

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

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Daniel Eisen, M.D.

University of California, Davis

More Information

No publications provided

Responsible Party:	Daniel Eisen, MD, Associate Professor of Clinical Dermatology, University of California, Davis
ClinicalTrials.gov Identifier:	NCT01770002 History of Changes
Other Study ID Numbers:	265161
Study First Received:	January 15, 2013
Last Updated:	January 18, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Melanoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 19, 2013

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