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

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Northwell Health

Status

Enrolling

Conditions

Skin Graft Scar

Treatments

Procedure: Simple interrupted suturing technique
Procedure: Running suturing technique

Study type

Interventional

Funder types

Other

Identifiers

NCT06233812
23-0413

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

52 participants in 2 patient groups

Half A of the FTSG
Active Comparator group
Description:
"A" (superior or left relative to the patient, depending on the shape of the wound)
Treatment:
Procedure: Running suturing technique
Procedure: Simple interrupted suturing technique
Half B of the FTSG
Active Comparator group
Description:
"B" (inferior or right relative to the patient).
Treatment:
Procedure: Running suturing technique
Procedure: Simple interrupted suturing technique

Trial contacts and locations

1

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Central trial contact

Marcus L Elias, MD

Data sourced from clinicaltrials.gov

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