Comparing two suturing techniques for skin grafts
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement: A Split-scar, Randomized, Non-inferiority Comparison
This study is testing whether a new way of stitching skin grafts looks just as good as the traditional method by comparing the results on the same person's scars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (N. New Hyde Park, New York) |
| Trial ID | NCT06233812 on ClinicalTrials.gov |
What this trial studies
This study compares the cosmetic outcomes of running epidermal sutures versus simple interrupted sutures in full-thickness skin graft placement following dermatologic surgery. It employs a split-scar design, where each participant's scar will receive both suturing techniques, allowing for direct comparison. The primary outcome will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) 2.0 by blinded observers at a 3-month follow-up. The goal is to determine if the more efficient running sutures are non-inferior in cosmetic results compared to traditional interrupted sutures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing full-thickness skin graft reconstruction after dermatologic surgery.
Not a fit: Patients not undergoing full-thickness skin graft placement or those unable to return for follow-up visits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical efficiency and patient satisfaction with cosmetic outcomes after skin graft procedures.
How similar studies have performed: While there have been multiple studies on suturing techniques, this specific comparison of running versus interrupted sutures in full-thickness skin grafts is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
N. New Hyde Park, New York
- Marcus Elias — N. New Hyde Park, New York, United States (Recruiting)
Study contacts
- Principal investigator: Victoria R Sharon, MD — Northwell Dermatology
- Study coordinator: Marcus L Elias, MD
- Email: melias2@northwell.edu
- Phone: 862-371-6427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.