Recruiting

Observational Study

Sponsor:

Melissa Pugliano-Mauro

Code:

NCT05408117

Conditions

Scar

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

5-0 Polypropylene epidermal suture

5-0 Fast gut epidermal suture

Study Details

Brief summary:

The present study assesses if dissolvable (fast gut) or non-dissolvable (polypropylene) epidermal sutures produce better cosmetic results in terms of dyspigmentation and scarring in patients of skin of color. Through a split-wound study design, patients undergoing standard elliptical excisions at least 3 cm in length will receive each suture type. Measurements of dyspigmentation and scarring will be made at 7 days (for the head and neck), 10 days (for the trunk and extremities), and 3 months for all locations.

Conditions

Scar

Study ID

NCT05408117

Start date

Oct 1, 2022

Status verified date

Jun, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Aug 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years or older
2. Undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater. Benign and malignant lesions will be included, including those that have undergone Mohs micrographic surgery prior to standard linear closure. All body sites will be included.
3. Able to give informed consent
4. Able to return for 3 month follow up
5. New Immigration Scale (NIS) skin color 4 or greater - The NIS is an 11 point scale, ranging from zero to 10, with zero representing albinism and 10 representing the darkest possible skin.

Exclusion Criteria:

1. High-tension closures not amenable to 5-0 simple running epidermal sutures
2. Known allergy to suture material
3. Pregnant

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A= left/superior half of wound

Patients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater

experimental: B= right/inferior half of wound

Patients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater

Interventions

5-0 Polypropylene epidermal suture

Split-wound, intra-individual comparison - half of wound will receive 5-0 polypropylene epidermal suture and half of wound will receive 5-0 fast gut epidermal suture

5-0 Fast gut epidermal suture

Split-wound, intra-individual comparison - half of wound will receive 5-0 polypropylene epidermal suture and half of wound will receive 5-0 fast gut epidermal suture

Primary outcome measure

  • POSAS [ Time Frame: Suture removal date which is 7 days from the procedure if the excision is on the head or neck and 10 days from the procedure if the excision is on the trunk or extremities ]
  • POSAS [ Time Frame: 3 months from procedure ]
  • Skin hyperpigmentation index [ Time Frame: 3 months from procedure ]

Central Contacts and Locations

Central contacts

Melissa Pugliano-Mauro, MD

412-784-7350puglianomauroma@upmc.edu

Jeffrey M Plowey, MS, ASCP(HTL)

412-784-7350ploweyjm2@upmc.edu

Locations

UPMC Presbyterian

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC St. Margaret

Recruiting

Pittsburgh, Pennsylvania, United States, 15215

UPMC Shadyside Place

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

More Information

Sponsor

Melissa Pugliano-Mauro

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • skin of color
  • split-wound
  • polypropylene
  • fast gut
  • pigmentary disturbance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Melissa Pugliano-Mauro on 2026-06-04.