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

NCT ID: NCT06233812

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-08-01

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.

Conditions

Skin Graft Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Half A of the FTSG

"A" (superior or left relative to the patient, depending on the shape of the wound)

Group Type: ACTIVE_COMPARATOR

Simple interrupted suturing technique

Intervention Type: PROCEDURE

Both simple interrupted and running epidermal sutures are considered acceptable, appropriate techniques for FTSG placement. Therefore, this study would be important in determining whether running sutures, the more efficient method, are non-inferior to simple interrupted sutures.

Running suturing technique

Intervention Type: PROCEDURE

Both simple interrupted and running epidermal sutures are considered acceptable, appropriate techniques for FTSG placement. Therefore, this study would be important in determining whether running sutures, the more efficient method, are non-inferior to simple interrupted sutures.

Half B of the FTSG

"B" (inferior or right relative to the patient).

Group Type: ACTIVE_COMPARATOR

Simple interrupted suturing technique

Intervention Type: PROCEDURE

Both simple interrupted and running epidermal sutures are considered acceptable, appropriate techniques for FTSG placement. Therefore, this study would be important in determining whether running sutures, the more efficient method, are non-inferior to simple interrupted sutures.

Running suturing technique

Intervention Type: PROCEDURE

Both simple interrupted and running epidermal sutures are considered acceptable, appropriate techniques for FTSG placement. Therefore, this study would be important in determining whether running sutures, the more efficient method, are non-inferior to simple interrupted sutures.

Interventions

Simple interrupted suturing technique

Both simple interrupted and running epidermal sutures are considered acceptable, appropriate techniques for FTSG placement. Therefore, this study would be important in determining whether running sutures, the more efficient method, are non-inferior to simple interrupted sutures.

Intervention Type: PROCEDURE

Running suturing technique

Both simple interrupted and running epidermal sutures are considered acceptable, appropriate techniques for FTSG placement. Therefore, this study would be important in determining whether running sutures, the more efficient method, are non-inferior to simple interrupted sutures.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria R Sharon, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Dermatology

Locations

Marcus Elias

North New Hyde Park, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marcus L Elias, MD

Role: CONTACT

melias2@northwell.edu

862-371-6427

Facility Contacts

Marcus L Elias, MD

Role: primary

melias2@northwell.edu

516-719-3376

Other Identifiers

23-0413

Identifier Type: -

Identifier Source: org_study_id