Aesthetic Outcome of Running Subcuticular Suture Versus Running Horizontal Mattress Suture Closure of Linear Wounds on the Trunk and Extremities

NCT05263713 | Completed

• 1 other identifier: 1813469
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the use of running subcuticular suture versus running horizontal mattress suture for the repair of cutaneous linear wounds on the trunk and extremities affects aesthetic outcomes. The study team will use a split wound model, where half of the wound is repaired with running subcuticular sutures and the other half is repaired with running horizontal mattress sutures. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. Any adverse events will also be recorded.

Conditions

Wound of Skin; Scar

Outcome Measures

Primary Outcomes (2)

• Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

  The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.

  3 months

• Width of Scar as measured using Trace-to-Tape Method

  The trace-to-tape method is an objective measure for linear postoperative scars. The mean scar width will be determined using the trace-to-tape method. The surface area of the scar will be collected by tracing the scar with a water-based gel pen. While still wet, the gel residue will be lifted from the skin with clear packing tape and transferred on a sheet of paper.

  3 months

Secondary Outcomes (1)

• Complications or Adverse Events from Treatment

  3 months

Study Arms (2)

Running Horizontal Mattress

EXPERIMENTAL

Half of the wound is repaired with running horizontal mattress sutures

Other: Suture Closure of Linear Wounds

Running Subcuticular Suture

EXPERIMENTAL

Half of the wound is repaired with running subcuticular sutures

Other: Suture Closure of Linear Wounds

Interventions

Suture Closure of Linear Wounds OTHER

Half of the wound is repaired with running subcuticular sutures and the other half is repaired with running horizontal mattress sutures.

Running Horizontal Mattress; Running Subcuticular Suture

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 trunk or extremities with predicted primary closure
• Willing to return for follow up visit

You may not qualify if:

• Incarceration
• Under 18 years of age
• Pregnant Women
• Wounds with predicted closure length less than 3 cm

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95816, United States

Location

Related Publications (3)

• Robinson, J. Surgery of the Skin. New York, NY: Elsevier. 2014.

  BACKGROUND

• Alam M, Posten W, Martini MC, Wrone DA, Rademaker AW. Aesthetic and functional efficacy of subcuticular running epidermal closures of the trunk and extremity: a rater-blinded randomized control trial. Arch Dermatol. 2006 Oct;142(10):1272-8. doi: 10.1001/archderm.142.10.1272.

  PMID: 17043181 BACKGROUND

• Moody BR, McCarthy JE, Linder J, Hruza GJ. Enhanced cosmetic outcome with running horizontal mattress sutures. Dermatol Surg. 2005 Oct;31(10):1313-6. doi: 10.1111/j.1524-4725.2005.31209.

  PMID: 16188185 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: At the follow-up visit, two blinded observers will record their scores independently using the POSAS instrument.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: March 3, 2022
• Study Start: November 1, 2021
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

US (1)