Skin Graft ScarNCT06233812
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
A study testing Simple interrupted suturing technique and Running suturing technique in people with Skin Graft Scar, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Graft Scar
- What is being tested?
- Simple interrupted suturing technique and Running suturing technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 29 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Marcus Elias
North New Hyde Park, New York, 11042
Marcus L Elias, MD, 516-719-3376, melias2@northwell.edu
Victoria R Sharon, MD
About this study
Official title: Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement: A Split-scar, Randomized, Non-inferiority Comparison
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.
Read the 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
- Being tested
- Simple interrupted suturing technique, Running suturing technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple interrupted suturing techniqueProcedure or surgery
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 techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Half A of the FTSG | Active comparator | "A" (superior or left relative to the patient, depending on the shape of the wound) Receives: Procedure: Simple interrupted suturing technique; Procedure: Running suturing technique |
| Half B of the FTSG | Active comparator | "B" (inferior or right relative to the patient). Receives: Procedure: Simple interrupted suturing technique; Procedure: Running suturing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: POSAS 2.0 observer total score at 3 months post-surgery, calculated as the average of two observers' total scores.
Secondary outcomes (3)
Clinician overall opinion
Clinician observer overall opinion of scar quality, measured on a 10-point scale (1-10) by two observers and averaged
Measured: through study completion, an average of 1 year
Patient overall opinion
Patient overall opinion of scar quality, measured on a 10-point scale (1-10)
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Aug 2023
- Primary completion29 Oct 2029 (estimated)
- Study completion29 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Graft ScarStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria R Sharon, MD, Principal investigator, Northwell Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233812
- Sponsor's protocol ID
- 23-0413
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement: A Split-scar, Randomized, Non-inferiority Comparison
- ClinicalTrials.gov ID
- NCT06233812
- Acronym / sponsor ID
- 23-0413
- Conditions
- Skin Graft Scar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 29 Oct 2029 (estimated)
- Study completion
- 29 Nov 2029 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Half A of the FTSG | Active comparator | Procedure: Simple interrupted suturing technique, Procedure: Running suturing technique"A" (superior or left relative to the patient, depending on the shape of the wound) |
| Half B of the FTSG | Active comparator | Procedure: Simple interrupted suturing technique, Procedure: Running suturing technique"B" (inferior or right relative to the patient). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple interrupted suturing techniqueBoth 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. | Procedure or surgery | Half A of the FTSG, Half B of the FTSG |
| Running suturing techniqueBoth 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. | Procedure or surgery | Half A of the FTSG, Half B of the FTSG |
Primary outcome
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.
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
3 secondary outcomes
Clinician overall opinion
Time frame: through study completion, an average of 1 year
Patient overall opinion
Time frame: through study completion, an average of 1 year
Complications
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Skin Graft Scar
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Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
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Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria R Sharon, MD principal investigator
Northwell Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple interrupted suturing technique and Running suturing technique in people with Skin Graft Scar, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus L Elias, MD (862-371-6427, melias2@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.