Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06448481
Status
Recruiting
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Conditions

  • Scarring

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intra-dermal purse-string closure — PROCEDURE
    Sutures are placed below the skin surface around a circular surgical wound, and the ends are cinched together like a coin purse.
  • Transcutaneous purse-string closure — PROCEDURE
    Sutures are placed through the skin surface around a circular surgical wound, and cinched together like a coin purse.

Study Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
Jan 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
73 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intra-dermal purse-string closure on Side A
    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.
  • Experimental: Intra-dermal purse-string closure on Side B
    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.

Primary Outcome Measure

Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Davis - Dermatology DepartmentSacramentoCalifornia95816
Salsala Nasim, BS
[email protected]
916-551-2636
Daniel Eisen, MD
[email protected]
916-551-2611
Daniel Eisen, MD (PRINCIPAL_INVESTIGATOR)

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University of California, Davis - Dermatology Department· Sacramento, CA

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