RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-01
Study Completion:2024-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06233812

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Inclusion criteria will capture patients
  2. * 18 years or older
  3. * have a FTSG reconstruction
  4. * any body site
  5. * to close to a primary defect after dermatologic surgery.
  1. * Not undergoing reconstruction with full-thickness skin-graft placement
  2. * FTSG not large enough to accommodate at least 3 interrupted sutures on one half side
  3. * Pregnancy or lactation
  4. * Under 18 years of age
  5. * Unable/unwilling to return for follow-up visits
  6. * Unable to provide consent (eg. unable to understand spoken/written English, mentally handicapped)

Contacts and Locations

Study Contact

Marcus L Elias, MD
CONTACT
862-371-6427
melias2@northwell.edu

Principal Investigator

Victoria R Sharon, MD
PRINCIPAL_INVESTIGATOR
Northwell Dermatology

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Northwell Health

  • Victoria R Sharon, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-08-01
Study Completion Date2024-08-01

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2024-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Skin Graft Scar