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

Skin Graft Scar Clinical Trial

Official title:

Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement: A Split-scar, Randomized, Non-inferiority Comparison

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233812
• Other study ID #: 23-0413
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: Northwell Health
• Contact: Marcus L Elias, MD
• Phone: 862-371-6427
• Email: melias2[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Skin Graft Scar

Intervention

Procedure:
• 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
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.

Locations

Country	Name	City	State
United States	Marcus Elias	N. New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Patient and Observer Scar Assessment Scale (POSAS)	Total observer score of the Patient and Observer Scar Assessment Scale (POSAS) 2.0; The patient score combines scar pain, itch, color, stiffness, thickness, and irregularity (1-10). The observer scale comprises of the items vascularity, pigmentation, thickness, relief, pliability, and surface area. All items of the patient and observer score combined will form a total POSAS score (the highest score represents the worst scar imaginable). It also consists of an overall opinion of the scar	POSAS 2.0 observer total score at 3 months post-surgery, calculated as the average of two observers' total scores.
Secondary	Clinician overall opinion	Clinician observer overall opinion of scar quality, measured on a 10-point scale (1-10) by two observers and averaged	through study completion, an average of 1 year
Secondary	Patient overall opinion	Patient overall opinion of scar quality, measured on a 10-point scale (1-10)	through study completion, an average of 1 year
Secondary	Complications	Number of patients experiencing bleeding requiring physician intervention after surgery Number of patients experiencing graft failure Number of patients developing infection between date of surgery and 3-month follow-up visit Number of patients with hypertrophic or keloidal scar formation Number of patients experiencing wound dehiscence (re-opening) between surgery and the 3-month follow-up visit	through study completion, an average of 1 year