Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement

NCT06233812 | Unknown

• 1 other identifier: 23-0413
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that the use of running epidermal sutures in full-thickness skin graft (FTSG) placement for patients undergoing dermatologic surgery (Mohs micrographic surgery or excision) is non-inferior to the use of simple interrupted sutures with respect to cosmetic outcome. This will be a split-scar (within-person) study, in which half of each participant's scar will receive the study intervention (running epidermal sutures), with the other half receiving the control intervention (simple interrupted sutures). The primary outcome, total observer score of the Patient and Observer Scar Assessment Scale (POSAS) 2.0, will be assessed by two blinded observers at a 3-month follow-up visit, and compared between scar halves.

Conditions

Skin Graft Scar

Outcome Measures

Primary Outcomes (1)

• The Patient and Observer Scar Assessment Scale (POSAS)

  Total observer score of the Patient and Observer Scar Assessment Scale (POSAS) 2.0 The patient score combines scar pain, itch, color, stiffness, thickness, and irregularity (1-10). The observer scale comprises of the items vascularity, pigmentation, thickness, relief, pliability, and surface area. All items of the patient and observer score combined will form a total POSAS score (the highest score represents the worst scar imaginable). It also consists of an overall opinion of the scar

  POSAS 2.0 observer total score at 3 months post-surgery, calculated as the average of two observers' total scores.

Secondary Outcomes (3)

• Clinician overall opinion

  through study completion, an average of 1 year

• Patient overall opinion

  through study completion, an average of 1 year

• Complications

  through study completion, an average of 1 year

Study Arms (2)

Half A of the FTSG

ACTIVE COMPARATOR

"A" (superior or left relative to the patient, depending on the shape of the wound)

Procedure: Simple interrupted suturing technique; Procedure: Running suturing technique

Half B of the FTSG

ACTIVE COMPARATOR

"B" (inferior or right relative to the patient).

Procedure: Simple interrupted suturing technique; Procedure: Running suturing technique

Interventions

Simple interrupted suturing technique PROCEDURE

Both simple interrupted and running epidermal sutures are considered acceptable, appropriate techniques for FTSG placement. Therefore, this study would be important in determining whether running sutures, the more efficient method, are non-inferior to simple interrupted sutures.

Half A of the FTSG; Half B of the FTSG

Running suturing technique PROCEDURE

Both simple interrupted and running epidermal sutures are considered acceptable, appropriate techniques for FTSG placement. Therefore, this study would be important in determining whether running sutures, the more efficient method, are non-inferior to simple interrupted sutures.

Half A of the FTSG; Half B of the FTSG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• have a FTSG reconstruction
• any body site
• to close to a primary defect after dermatologic surgery.
• The authors will exclude patients not undergoing reconstruction with full-thickness skin-graft placement, unable to return for follow-up visits, unable to provide consent (eg. unable to understand spoken/written English, mentally handicapped), and patients under 18 years of age. Male and female patients are eligible. Planned enrollment based on a priori sample size calculation is 52 patients.

You may not qualify if:

• Not undergoing reconstruction with full-thickness skin-graft placement
• FTSG not large enough to accommodate at least 3 interrupted sutures on one half side
• Pregnancy or lactation
• Under 18 years of age
• Unable/unwilling to return for follow-up visits
• Unable to provide consent (eg. unable to understand spoken/written English, mentally handicapped)

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Marcus Elias

North New Hyde Park, New York, 11042, United States

RECRUITING

Study Officials

• Victoria R Sharon, MD

  Northwell Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus L Elias, MD

CONTACT

862-371-6427; melias2@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will serve as their own controls -- one half of the full-thickness skin graft will be sutured with simple running sutures and the other half with simple interrupted sutures.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 31, 2024
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)