Wound Closure Methods for Scar Appearance

Overseen By John Robb, BS, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Incarceration, Under 18, Pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of wound closure to determine which results in better-looking scars and fewer complications. It specifically compares intra-dermal (inside the skin) and transcutaneous (through the skin) purse-string sutures. Each participant will have a wound closed with both methods on different halves for comparison. Individuals scheduled for skin surgery on the head, neck, or limbs, who can return for a follow-up visit, might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance wound care techniques.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these wound closure methods are safe?

Research shows that both intra-dermal and transcutaneous purse-string closures are generally well-tolerated by patients.

For intra-dermal closures, studies indicate that this method usually results in good healing with minimal scarring. One study found infections to be rare. Another study noted that while some wounds reopened, poor skin quality, not the closure method, was the primary cause.

Transcutaneous closures also have a strong safety record. Research found no serious issues, such as infections or bleeding, with this method. It is often used to minimize scar size without affecting the final appearance.

Overall, both methods appear safe and effective for closing wounds, with few reported problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two unique techniques for closing wounds with the goal of improving scar appearance. Unlike traditional sutures or staples, which can sometimes leave noticeable marks, the intra-dermal and transcutaneous purse-string closures distribute tension evenly across the wound. This could lead to a more aesthetically pleasing scar, as the techniques aim to minimize skin distortion and scarring. By comparing these two methods directly on opposite sides of the same wound, the trial hopes to determine which technique offers better cosmetic results.

What evidence suggests that these wound closure methods are effective for scar appearance?

This trial will compare two wound closure methods: intra-dermal purse-string closure and transcutaneous purse-string closure. Research has shown that both under-the-skin (intra-dermal) and through-the-skin (transcutaneous) stitching methods lead to similar cosmetic results. A 2015 study found that both techniques resulted in scars of similar size and pain levels. Another study observed good overall healing with under-the-skin stitching, with few issues like infection. Meanwhile, through-the-skin stitching has been linked to a lower risk of wound infection compared to other methods. Both techniques effectively close wounds, and complications are generally low, suggesting that both methods could improve the appearance of scars. ^{1 2 5 6 7}

Who Is on the Research Team?

Daniel Eisen, MD

Principal Investigator

University of California, Davis - Dermatology

Are You a Good Fit for This Trial?

This trial is for individuals with scars who are undergoing surgery that requires wound closure. The study will compare two different stitching techniques to see which results in better-looking scars and fewer complications.

Inclusion Criteria

Able to give informed consent themselves

Willing to return for follow up visit

I am scheduled for skin surgery with a specific type of closure.

Exclusion Criteria

Incarceration

Pregnant Women

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with split-wound model using intra-dermal and transcutaneous purse-string closures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for scar assessment and post-operative complications using POSAS and Trace-to-Tape methods

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intra-dermal purse-string closure
• Transcutaneous purse-string closure

Trial Overview The study tests intra-dermal versus transcutaneous purse-string closures on wounds. Each patient's wound is split; one half gets the intra-dermal method, the other half gets the transcutaneous method. Scar appearance and any complications are assessed after three months.

How Is the Trial Designed?

Group I: Intra-dermal purse-string closure on Side B Experimental Treatment 2 Interventions

For all participants, one wound side half will be labeled as A and the other side as B. Side B will be closed with a intra-dermal purse-string closure, and Side A will be closed with a transcutaneous purse-string closure.

Group II: Intra-dermal purse-string closure on Side A Experimental Treatment 2 Interventions

For all participants, one wound side half will be labeled as A and the other side as B. Side A will be closed with a intra-dermal purse-string closure, and Side B will be closed with a transcutaneous purse-string closure.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06448481

Aesthetic Outcome of Intra-dermal Versus Transcutaneous ... In 2015, a randomized trial comparing secondary intention healing to intradermal purse-string closure found similar cosmetic outcomes, scar size and pain level ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7651757/

Four Quadrant-Embedded Purse-String Closure for Defects ... The wounds showed good final healing without obvious adverse events postoperatively. Infection occurred only in three patients.

3. ctv.veeva.com ctv.veeva.com/study/aesthetic-outcome-of-intra-dermal-versus-transcutaneous-purse-string-closure

Aesthetic Outcome of Intra-dermal Versus Transcutaneous ... In 2015, a randomized trial comparing secondary intention healing to intradermal purse-string closure found similar cosmetic outcomes, scar ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9636732/

A prospective study of 'circumferential purse-string ... The mean healing time of wound in linear closure group and purse string group was 10.76 ± 5.68 days and 14.17 ± 2.04 days respectively. There was significant ...

5. withpower.com withpower.com/trial/wound-closure-methods-for-scar-appearance-edc76

Wound Closure Methods for Scar Appearance Research shows that the purse-string suture technique, which is similar to the treatments being studied, can effectively close skin wounds with minimal ...

6. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/1922025

Purse-String Suture vs Second Intention Healing The purse-string suture results in similar cosmetic outcomes, scar sizes, and pain levels compared with second intention healing for circular or oval wounds.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8413920/

Surgical refinement of the purse-string suture for skin and soft ... The purse-string suture (PSS) is a simple and rapid wound closure method that results in minimal scarring. It has been used to treat circular or oval skin ...