Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
|ClinicalTrials.gov Identifier: NCT01770002|
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : April 16, 2015
|Condition or disease||Intervention/treatment|
|Basal Cell Carcinoma Squamous Cell Carcinoma Melanoma||Procedure: Everted suture technique Procedure: Non-everted suture technique|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?|
|Study Start Date :||January 2012|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2014|
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|
- 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.
- 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.
- Scar measurements (height, width, length) [ Time Frame: 3 and 6 months ]Scar volume will be measured in centimeters on both sides of the wound
- Scar induration [ Time Frame: 3 and 6 months ]Scar induration area will be measured in centimeters for both sides of the wound
- Scar erythema [ Time Frame: 3 and 6 months ]Scar erythema area will be measured in centimeters for both sides of the wound
- 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
- 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
- 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
- Hyperpigmentation area [ Time Frame: 3 and 6 months ]areas of hyperpigmentation will be measured via a length x width measurement in centimeters
- Infection [ Time Frame: up to 6 months ]Infections occurring anytime during the study period will be recorded
- wound dehiscence [ Time Frame: up to 6 months ]incidence of wound infection will be recorded anytime during the study period
- spitting sutures [ Time Frame: 3 and 6 months ]spitting sutures will be counted for each side of the wound at 3 and 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770002
|United States, California|
|UC Davis, Department of Dermatology|
|Sacramento, California, United States, 95816|
|Principal Investigator:||Daniel Eisen, M.D.||University of California, Davis|