73 Participants Needed

Wound Closure Methods for Scar Appearance

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Intra-dermal purse-string closure, Transcutaneous purse-string closure 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 scarring. It has been used successfully to reduce the size of scars and improve healing in various types of skin defects, including those from tumor excisions.12345

Is the purse-string suture method safe for wound closure in humans?

The purse-string suture method has been used in humans for closing skin defects with minimal scarring, and it is generally considered safe. In a study involving 196 patients, complications were relatively low, with 10.4% experiencing wound reopening, often due to poor skin quality or using too small sutures. Overall, patient satisfaction with the results is high, especially for large facial excisions.12456

How does the purse-string suture treatment differ from other treatments for wound closure?

The purse-string suture treatment is unique because it can reduce the size of circular or oval wounds, potentially minimizing scarring and the need for skin grafts. It offers versatility by being applicable to various wound sizes and locations, and it can be used when linear closure is not possible, maintaining local tissue architecture.12347

What is the purpose of this trial?

The purpose of this study is to determine whether intra-dermal versus transcutaneous purse-string closures have similar scar cosmesis and post-operative complications. The investigators will use a split wound model, where half of the wound will be closed with intra-dermal purse-string sutures and the other half will be closed with a transcutaneous purse-string sutures. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. Any adverse events will also be recorded.

Research Team

Daniel Eisen - UC Davis Department of ...

Daniel Eisen, MD

Principal Investigator

University of California, Davis - Dermatology

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Intra-dermal purse-string closure on Side BExperimental Treatment2 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 AExperimental Treatment2 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

References

Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. [2016]
Closure of round cutaneous defects progressively with the purse string suture technique. [2018]
Versatility of the subcuticular purse-string suture in wound closure. [2019]
A simple technique for the excision of cutaneous carcinoma: the round block purse-string suture. [2021]
The "round block" purse-string suture: a simple method to close skin defects with minimal scarring. [2019]
Safety and feasibility of percutaneous skin closure using purse-string suture compared with compression bandage after pulmonary vein isolation. [2018]
Use of a Purse-String Suture to Reduce Skin Graft Requirements. [2022]
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