Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

Melanoma Clinical Trial

Official title:

Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770002
• Other study ID #: 265161
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: April 15, 2015
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Melanoma
• Squamous Cell Carcinoma

Intervention

Procedure:
• Everted suture technique

• Non-everted suture technique

Locations

Country	Name	City	State
United States	UC Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 and 6 months	No
Primary	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.	3 and 6 months	No
Primary	Scar measurements (height, width, length)	Scar volume will be measured in centimeters on both sides of the wound	3 and 6 months	No
Primary	Scar induration	Scar induration area will be measured in centimeters for both sides of the wound	3 and 6 months	No
Primary	Scar erythema	Scar erythema area will be measured in centimeters for both sides of the wound	3 and 6 months	No
Primary	Wound contour irregularities	Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement	3 and 6 months	No
Primary	Stand cone volume	The volume of standing cones will be measured via length, width and height measurements in centimeters	3 and 6 months	No
Primary	Uneven edge measurement	The area of uneven edges will be measured via a length x height measurement in centimeters	3 and 6 months	No
Primary	Hyperpigmentation area	areas of hyperpigmentation will be measured via a length x width measurement in centimeters	3 and 6 months	No
Secondary	Infection	Infections occurring anytime during the study period will be recorded	up to 6 months	Yes
Secondary	wound dehiscence	incidence of wound infection will be recorded anytime during the study period	up to 6 months	Yes
Secondary	spitting sutures	spitting sutures will be counted for each side of the wound at 3 and 6 months	3 and 6 months	No

External Links

•   University of California-Davis Department of Dermatology Clinical Research