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NCT Number: NCT06448481

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

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.

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Key information

Conditions

Scarring Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

Location status: Recruiting

Location contact

Daniel Eisen, MD

CONTACT

[email protected]

916-551-2611

Daniel Eisen, MD

PRINCIPAL_INVESTIGATOR

Salsala Nasim, BS

CONTACT

[email protected]

916-551-2636

About this study

The purse-string closure is a versatile technique that utilizes circumferential tissue advancement for partial or complete closure of circular cutaneous surgical defects. First reported in the 1950s for closure of a malar defect, the purse-string closure is now routinely used for umbilical, urethral, and breast defects as well as for cutaneous surgical defects either alone or in conjunction with top sutures, local flaps, or grafts.

Though the purse-string closure was initially described with circumferentially placed intradermal sutures, various modifications to this technique have been published including sub-cuticular, intra-dermal, and cuticular variations. All modifications of the purse-string closure share the advantages of reduced operating time, decreased defect and scar size, no removal of normal tissue, low hematoma risk, and faster healing time. However, several papers suggest that cuticular (transcutaneous) purse-string closures may be superior to intra-dermal purse-string closures due to enhanced hemostasis from greater compression of the dermal vessels, greater utility in atrophic and actinically damaged skin, lower risk of dermal dehiscence, and better efficacy in skin with limited laxity.

In 2015, a randomized trial comparing secondary intention healing to intradermal purse-string closure found similar cosmetic outcomes, scar size and pain level between the intra-dermal purse-string closure and secondary intention healing however similar studies comparing intra-dermal and transcutaneous purse-string closures are lacking. Given the potential functional advantages of the transcutaneous purse-string closure over the intra-dermal purse-string closure, additional studies comparing the two variations of the purse-string closure are needed to guide clinical practice.

The aesthetic outcome and rate of post-operative complications of intra-dermal versus transcutaneous purse-string closures have not been studied. This study seeks to compare the effectiveness of transcutaneous purse-string sutures to intra-dermal purse-string sutures by using individuals as their own controls in a split-scar model.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure on the head, neck, trunk, or extremities with predicted purse-string closure.
  • Willing to return for follow up visit

Exclusion criteria

  • Incarceration
  • Under 18 years of age
  • Pregnant Women

Treatment and study plan

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.

Primary outcomes

  1. Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

    Time frame: 3 months

    The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.

Secondary outcomes

  1. Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

    Time frame: 3 months

    This is the patient portion of the POSAS assessment, which will be independently recorded. The patient scale of the POSAS consists of six items (pain, itch, thickness, color, stiffness, and irregularity). All items are scored on a scale ranging from 1 ("as normal skin") to 10 ("yes, very different"). The sum of the six items results in a total score of the POSAS patient scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.

  2. Width of Scar as measured using Trace-to-Tape Method

    Time frame: 3 months

    The trace-to-tape method is an objective measure for linear postoperative scars. The mean scar width will be determined using the trace-to-tape method. The surface area of the scar will be collected by tracing the scar with a water-based gel pen. While still wet, the gel residue will be lifted from the skin with clear packing tape and transferred on a sheet of paper.

  3. Complications or Adverse Events from Treatment

    Time frame: 3 months

    For example, if one half of the scar has more associated erythema, as measured using the Trace-to-Tape method, then it will be recorded. Other complications from the treatment will also be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Salsala Nasim, BS

CONTACT

[email protected]

916-551-2636

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 7, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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