Clinical trial NCT06233812: Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Official title: Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement: A Split-scar, Randomized, Non-inferiority Comparison
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Graft Scar
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will serve as their own controls -- one half of the full-thickness skin graft will be sutured with simple running sutures and the other half with simple interrupted sutures.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility 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)

Primary outcomes:
measure: The Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: POSAS 2.0 observer total score at 3 months post-surgery, calculated as the average of two observers' total scores.
Secondary outcomes:
measure: Clinician overall opinion
timeFrame: through study completion, an average of 1 year
measure: Patient overall opinion
timeFrame: through study completion, an average of 1 year
measure: Complications
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: N. New Hyde Park
country: United States
facility: Marcus Elias
state: New York
Study officials:
affiliation: Northwell Dermatology
name: Victoria R Sharon, MD
role: PRINCIPAL_INVESTIGATOR
References: