Recruiting

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

Sponsor:

Northwell Health

Code:

NCT06233812

Conditions

Skin Graft Scar

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Simple interrupted suturing technique

Running suturing technique

Study Details

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.

Conditions

Skin Graft Scar

Study ID

NCT06233812

Start date

Aug 1, 2023

Status verified date

Jan, 2024

Completion date

Aug 1, 2024

Anticipated

Primary completion date

Aug 1, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Half A of the FTSG

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

active comparator: Half B of the FTSG

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

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.

Running suturing technique

Primary outcome measure

The Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: POSAS 2.0 observer total score at 3 months post-surgery, calculated as the average of two observers' total scores. ]

Central Contacts and Locations

Central contacts

Marcus L Elias, MD

862-371-6427 melias2@northwell.edu

Locations

Marcus Elias

Recruiting

N. New Hyde Park, New York, United States, 11042

Contacts

Marcus L Elias, MD

516-719-3376 melias2@northwell.edu

Principal Investigator:

Victoria R Sharon, MD

More Information

Sponsor

Northwell Health

Last update posted

Jan 31, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-01-31.