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: June 18, 2014
Last verified: June 2014
  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:


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 2014
Estimated Primary Completion Date: October 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 18, 2014
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 August 28, 2014