Comparison of Cosmetic Outcomes of Straight Line and W-plasty Techniques for Linear Wound Closure

NCT05074199 | Completed

• 1 other identifier: 1195990
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the cosmetic outcome of traditional straight-line (SL) linear closure to that of W plasty (a type of geometric broken-line cutaneous closure technique) for closure of post-auricular wounds resulting from harvest of full thickness skin grafts during Mohs micrographic surgery. The research team will use a split wound model, where half of the wound is repaired with a straight-line cutaneous closure and the other half is repaired with the W-plasty technique. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale (POSAS), a validated scar instrument. The scar width, and adverse events will also be recorded.

Conditions

Suture Dermatologic; Surgery; Cosmetic Outcome

Outcome Measures

Primary Outcomes (1)

• Patient Observer Scar Assessment Scale (POSAS) scores

  The primary outcome is the difference in Patient Observer Scar Assessment Scale (POSAS) scores between the halves of the wound (standard linear closure versus W-plasty). The POSAS instrument incorporates separate questionnaires for observers and patients. Each questionnaire contains six items with possible scores from 0-10 for a total maximum score of 60 on each component (patient and observer).

  3-12 months

Study Arms (2)

W-plasty

ACTIVE COMPARATOR

The cosmetic appearance of scars closed in a in a "zig-zag" " fashion (W-plasty).

Procedure: W-plasty/Linear closure

Linear closure

ACTIVE COMPARATOR

The cosmetic appearance of scars closed in a standard "straight line" fashion (linear closure).

Procedure: W-plasty/Linear closure

Interventions

W-plasty/Linear closure PROCEDURE

The patient's wound will be labeled A if it is on the left or superior side of the investigator and B if it is on the right or inferior side. A predetermined, concealed randomization number will be obtained from the RedCap randomization module, which will specify how side A is to be treated. Side B will be treated the opposite way as A. Side A will always be closed first. The side assigned to be closed in a traditional straight line (SL) will have the standing cutaneous deformity ("dog ear") excised in the standard manner using Burrow's triangles, resulting in an elliptical defect amenable to linear closure. The side assigned to be closed with W-plasty will have the dog ear excised in a zig-zag fashion consistent with the W plasty flap design. Both sides of the wound will receive subcuticular closure with interrupted subdermal sutures as is the standard of care, followed by a standard running cuticular closure with absorbable suture material.

Linear closure; W-plasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to give informed consent themselves
• Patient scheduled for cutaneous surgical procedure on the head or face for which a full thickness skin graft will be used as part of the reconstruction or has a lesion that will be excised in mastoid area of the neck, behind the ear.
• Willing to return for follow up visit.

You may not qualify if:

• Wounds predicted to be less than 3 cm in size after closure.
• Unable to understand written and oral English
• Incarceration
• Under 18 years of age
• Pregnant Women

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95816, United States

Location

Related Publications (1)

• Mehrzad M, Kang AS, Armstrong AW, Eisen DB. Comparing Cosmetic Outcomes of Straight-Line Versus W-Plasty Techniques for Linear Postauricular Wound Closure: A Randomized Evaluator Blind Split-Scar Trial. Dermatol Surg. 2024 May 1;50(5):423-427. doi: 10.1097/DSS.0000000000004113. Epub 2024 Feb 28.

  PMID: 38416811 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: February 26, 2018
• Primary Completion: August 31, 2021
• Study Completion: September 1, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)