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

January 22, 2024 updated by: Northwell Health

Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement: A Split-scar, Randomized, Non-inferiority Comparison

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A FTSG is used in lieu of linear repair or local tissue skin flap rearrangement when surrounding skin tissue laxity is unavailable or the patient prefers a graft instead. Typically the skin for a FTSG is harvested from a local or distant donor site depending on skin tissue match and tissue availability and sutured into place. The site where the FTSG was taken is primarily repaired or allowed to heal via second intent. This study is important because it provides a comparison of cosmetic outcome between interrupted versus running cutaneous sutures. The information provided would help determine if a more efficient suturing technique is non-inferior to a less efficient one, thus saving time for the patient and provider. There is no current standard of practice, with dermatologic surgeons using both interrupted and running sutures, as there is a paucity of literature on this topic as related to full thickness grafts after dermatologic surgery. Running epidermal sutures are more time efficient and thus decrease patient intra-operative time, save on suture material, increase surgeon productivity, and may improve the overall patient operative experience. There have been multiple other split scar studies and studies related to the cosmetic outcomes of various suturing practices. However, there have been none that have looked at simple versus running epidermal stitching of FTSG placement.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • N. New Hyde Park, New York, United States, 11042
        • Recruiting
        • Marcus Elias
        • Contact:
        • Principal Investigator:
          • Victoria R Sharon, MD
        • Sub-Investigator:
          • Andrew Strunk, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Inclusion criteria will capture patients
  • 18 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Half A of the FTSG
"A" (superior or left relative to the patient, depending on the shape of the wound)
Procedure: Simple interrupted suturing technique
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.
Procedure: Running suturing technique
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.
Active Comparator: Half B of the FTSG
"B" (inferior or right relative to the patient).
Procedure: Simple interrupted suturing technique
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.
Procedure: Running suturing technique
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: POSAS 2.0 observer total score at 3 months post-surgery, calculated as the average of two observers' total scores.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician overall opinion
Time Frame: through study completion, an average of 1 year
Clinician observer overall opinion of scar quality, measured on a 10-point scale (1-10) by two observers and averaged
through study completion, an average of 1 year
Patient overall opinion
Time Frame: through study completion, an average of 1 year
Patient overall opinion of scar quality, measured on a 10-point scale (1-10)
through study completion, an average of 1 year
Complications
Time Frame: through study completion, an average of 1 year
Number of patients experiencing bleeding requiring physician intervention after surgery Number of patients experiencing graft failure Number of patients developing infection between date of surgery and 3-month follow-up visit Number of patients with hypertrophic or keloidal scar formation Number of patients experiencing wound dehiscence (re-opening) between surgery and the 3-month follow-up visit
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Victoria R Sharon, MD, Northwell Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 23-0413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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