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OpenTrials
Completed

NCT Number: NCT01770002

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

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis, Department of Dermatology

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everted suture technique

Procedure

Non-everted suture technique

Procedure

Primary outcomes

  1. 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.

  2. 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. Scar measurements (height, width, length)

    Time frame: 3 and 6 months

    Scar volume will be measured in centimeters on both sides of the wound

  4. Scar induration

    Time frame: 3 and 6 months

    Scar induration area will be measured in centimeters for both sides of the wound

  5. Scar erythema

    Time frame: 3 and 6 months

    Scar erythema area will be measured in centimeters for both sides of the wound

  6. 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

  7. 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

  8. 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

  9. Hyperpigmentation area

    Time frame: 3 and 6 months

    areas of hyperpigmentation will be measured via a length x width measurement in centimeters

Secondary outcomes

  1. Infection

    Time frame: up to 6 months

    Infections occurring anytime during the study period will be recorded

  2. wound dehiscence

    Time frame: up to 6 months

    incidence of wound infection will be recorded anytime during the study period

  3. spitting sutures

    Time frame: 3 and 6 months

    spitting sutures will be counted for each side of the wound at 3 and 6 months

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 17, 2013
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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