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Suture Types for Scarring in Darker Skin Tones

N/A
Recruiting
Led By Melissa Pugliano-Mauro, MD
Research Sponsored by Melissa Pugliano-Mauro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
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.
Must not have
High-tension closures not amenable to 5-0 simple running epidermal sutures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months from procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether dissolvable or non-dissolvable stitches create better cosmetic results in terms of scarring and pigmentation for patients with darker skin tones.

Who is the study for?
This trial is for adults over 18 with skin color NIS scale of 4 or higher, undergoing dermatologic surgery needing at least a 3 cm incision. They must be able to consent, return for follow-up after 3 months, and can have benign or malignant lesions. It's not for those allergic to suture materials, pregnant women, or cases requiring high-tension closures.
What is being tested?
The study compares dissolvable (fast gut) versus non-dissolvable (polypropylene) sutures in patients of darker skin tones to see which causes less scarring and pigment changes post-surgery. Each patient will receive both types on different halves of the same wound.
What are the potential side effects?
Potential side effects may include varying degrees of dyspigmentation (changes in skin color), scarring where the sutures are placed, and typical risks associated with suture materials such as infection or reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am having skin surgery for a lesion larger than 3 cm, including after Mohs surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My wound cannot be closed with simple stitches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months from procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months from procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
POSAS
Skin hyperpigmentation index
Secondary study objectives
Complications
Scar width

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: B= right/inferior half of woundExperimental Treatment2 Interventions
Patients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater
Group II: A= left/superior half of woundExperimental Treatment2 Interventions
Patients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater

Find a Location

Who is running the clinical trial?

Melissa Pugliano-MauroLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Melissa Pugliano-Mauro, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

B= right/inferior half of wound Clinical Trial Eligibility Overview. Trial Name: NCT05408117 — N/A
Scarring Research Study Groups: B= right/inferior half of wound, A= left/superior half of wound
Scarring Clinical Trial 2023: B= right/inferior half of wound Highlights & Side Effects. Trial Name: NCT05408117 — N/A
B= right/inferior half of wound 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408117 — N/A
~6 spots leftby Jun 2025
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