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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Skin Graft Scar
Intervention / Treatment

-

Contacts and Locations

N. New Hyde Park

Marcus Elias, N. New Hyde Park, New York, United States, 11042

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Northwell Health,

Victoria R Sharon, MD, PRINCIPAL_INVESTIGATOR, Northwell Dermatology

Study Record Dates

2024-08-01