NCT06448481

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Oct 2025Jan 2027

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 14, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

June 3, 2024

Last Update Submit

January 27, 2026

Conditions

Scarring

Keywords

Purse-string

Outcome Measures

Primary Outcomes (1)

  • Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

    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.

    3 months

Secondary Outcomes (3)

  • Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

    3 months

  • Width of Scar as measured using Trace-to-Tape Method

    3 months

  • Complications or Adverse Events from Treatment

    3 months

Study Arms (2)

Intra-dermal purse-string closure on Side A

EXPERIMENTAL

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.

Procedure: Intra-dermal purse-string closureProcedure: Transcutaneous purse-string closure

Intra-dermal purse-string closure on Side B

EXPERIMENTAL

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.

Procedure: Intra-dermal purse-string closureProcedure: Transcutaneous purse-string closure

Interventions

Intra-dermal purse-string closurePROCEDURE

Sutures are placed below the skin surface around a circular surgical wound, and the ends are cinched together like a coin purse.

Intra-dermal purse-string closure on Side AIntra-dermal purse-string closure on Side B
Transcutaneous purse-string closurePROCEDURE

Sutures are placed through the skin surface around a circular surgical wound, and cinched together like a coin purse.

Intra-dermal purse-string closure on Side AIntra-dermal purse-string closure on Side B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Incarceration
  • Under 18 years of age
  • Pregnant Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

RECRUITING

Related Publications (9)

  • Joo J, Custis T, Armstrong AW, King TH, Omlin K, Kappel ST, Eisen DB. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. JAMA Dermatol. 2015 Mar;151(3):265-70. doi: 10.1001/jamadermatol.2014.2313.

    PMID: 25372450BACKGROUND

  • Scholl L, Meier NM, Hessam S, Valavanis K, Bechara FG. Subcuticular and cuticular purse-string sutures in dermatologic surgery. J Dtsch Dermatol Ges. 2016 Feb;14(2):196-8. doi: 10.1111/ddg.12896. Epub 2016 Jan 20. No abstract available.

    PMID: 26788857BACKGROUND

  • Fioramonti P, Sorvillo V, Maruccia M, Lo Torto F, Marcasciano M, Ribuffo D, Cigna E. New application of purse string suture in skin cancer surgery. Int Wound J. 2018 Dec;15(6):893-899. doi: 10.1111/iwj.12941. Epub 2018 Jun 29.

    PMID: 29956469BACKGROUND

  • Park S, Oh Y, Lee JW, Choi S, Nam KA, Roh MR, Chung KY. Various Applications of Purse-String Suture and Its Cosmetic Outcome in Cutaneous Surgical Defects. Ann Dermatol. 2023 Apr;35(2):100-106. doi: 10.5021/ad.21.263.

    PMID: 37041703BACKGROUND

  • Cohen PR, Martinelli PT, Schulze KE, Nelson BR. The cuticular purse string suture: a modified purse string suture for the partial closure of round postoperative wounds. Int J Dermatol. 2007 Jul;46(7):746-53. doi: 10.1111/j.1365-4632.2007.03253.x.

    PMID: 17614809BACKGROUND

  • Cohen PR, Martinelli PT, Schulze KE, Nelson BR. The purse-string suture revisited: a useful technique for the closure of cutaneous surgical wounds. Int J Dermatol. 2007 Apr;46(4):341-7. doi: 10.1111/j.1365-4632.2007.03204.x.

    PMID: 17442069BACKGROUND

  • Weisberg NK, Greenbaum SS. Revisiting the purse-string closure: some new methods and modifications. Dermatol Surg. 2003 Jun;29(6):672-6. doi: 10.1046/j.1524-4725.2003.29160.x.

    PMID: 12786718BACKGROUND

  • Lam TK, Lowe C, Johnson R, Marquart JD. Secondary Intention Healing and Purse-String Closures. Dermatol Surg. 2015 Oct;41 Suppl 10:S178-86. doi: 10.1097/DSS.0000000000000480.

    PMID: 26418684BACKGROUND

  • Raposio E, Antonacci M, Caruana G. A simple technique for the excision of cutaneous carcinoma: the round block purse-string suture. World J Surg Oncol. 2014 Aug 20;12:263. doi: 10.1186/1477-7819-12-263.

    PMID: 25142636BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Eisen, MD

    University of California, Davis - Dermatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salsala Nasim, BS

CONTACT

916-551-2636sanasim@health.ucdavis.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Two blinded observers will record their scores independently using the POSAS instrument.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

October 14, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

US(1)