Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Status unconfirmed · Not applicable
Conditions studied: Skin Graft Scar
In brief
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.
Key facts
- Study ID
- NCT06233812
- Run by
- Northwell Health
- People needed
- 52
- Starts
- 2023-08-01
- Expected to finish
- 2024-08-01
- Last updated by the study team
- 2024-01-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
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)
Where it is running
- Marcus Elias — North New Hyde Park, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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