Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05408117

Impact of Suture Type on Pigment Disturbances in Patients of Skin of Color: A Prospective, Randomized Split-wound Study

Led by Melissa Pugliano-Mauro · Updated on 2026-06-04

34

Participants Needed

3

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether dissolvable (fast gut) or non-dissolvable (polypropylene) epidermal sutures result in better cosmetic outcomes regarding pigment changes and scarring in patients with skin of color. This study uses a split-wound design where each patient receives both types of sutures on different halves of the same wound. Measurements of pigmentation and scarring will be taken at 7 or 10 days depending on the wound location, and again at 3 months after surgery. During surgery, patients will undergo standard elliptical excision with a wound length of at least 3 cm. A single buried intradermal suture will be placed centrally using polyglactin 910, with additional sutures placed symmetrically if needed. The wound will be divided into two halves, randomly assigned to receive either 5-0 fast gut or 5-0 polypropylene epidermal sutures, applied with a running technique. Sutures on the polypropylene side will be removed at 7 days for head and neck wounds, or 10 days for trunk and extremities, while residual fast gut sutures will be removed to keep observers blinded. Participants will have photos taken and scars assessed using the Patient and Observer Scar Assessment Scale (POSAS) at suture removal and again at 3 months post-surgery. Scar width, pain during suture removal, and skin hyperpigmentation index scores from dermatoscopic images will also be recorded. Clinical complications will be monitored, and patients unable to attend the 3-month visit will complete assessments remotely. All collected data will be analyzed to compare the cosmetic outcomes of the two suture types.

CONDITIONS

Brief Title

Impact of Suture Type on Pigment Disturbances in Patients of Skin of Color

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater
  • Able to give informed consent
  • Able to return for 3 month follow up
  • New Immigration Scale (NIS) skin color 4 or greater
Not Eligible

You will not qualify if you...

  • High-tension closures not suitable for 5-0 simple running epidermal sutures
  • Known allergy to suture material
  • Pregnant

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Implementation

Duration - Day of surgery

Participants undergo dermatologic surgery with a standard elliptical excision and receive two different types of epidermal sutures on each half of their wound as part of the study intervention.

1 in-person surgery visit

Post-operative Follow-up

Duration - 7 to 10 days after surgery depending on wound location

Participants have sutures removed and undergo scar assessment including photos, scar scoring, scar width measurement, and pain evaluation shortly after surgery.

1 in-person suture removal visit

Post-operative Follow-up

Duration - 3 months after surgery

Participants return for scar evaluation including photos, scar scoring, dermatoscopic imaging, scar width measurement, and clinical assessment of wound healing and complications.

1 in-person follow-up visit with possible telephone follow-up if in-person visit is missed

Trial Site Locations

Total: 3 locations

1

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

2

UPMC St. Margaret

Pittsburgh, Pennsylvania, United States, 15215

Actively Recruiting

3

UPMC Shadyside Place

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

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Research Team

M

Melissa Pugliano-Mauro, MD

J

Jeffrey M Plowey, MS, ASCP(HTL)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

5-0 Polypropylene versus 5-0 fast absorbing plain gut for cutaneous wound closure: a randomized evaluator blind trial.

Daniel Brian Eisen, Anne Rang Zhuang, Aliza Hasan...

https://pubmed.ncbi.nlm.nih.gov/31724097

The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation.

Lieneke J Draaijers, Fenike R H Tempelman, Yvonne A M Botman...

https://pubmed.ncbi.nlm.nih.gov/15253184

Comparison of Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis of the Face and Neck: A Randomized Clinical Trial.

Lindsay R Sklar, Aunna Pourang, April W Armstrong...

https://pubmed.ncbi.nlm.nih.gov/30649154