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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months from procedure

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am 18 years old or older.

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I am having skin surgery for a lesion larger than 3 cm, including after Mohs surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months from procedure

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

POSAS

Skin hyperpigmentation index

Secondary outcome measures

Complications

Scar width

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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in this medical experiment thus far?

"Affirmative. Clinicaltrials.gov hosts information that confirms this medical experiment is currently seeking volunteers, and was first publicized on October 1st 2022 followed by a recent update on the 6th of the same month. The research team needs to enlist 34 patients from 3 locations to complete the trial."

Answered by AI

Is this research experiment currently open to new participants?

"According to the data posted on clinicaltrials.gov, this medical trial is actively searching for potential candidates. The original advert was published on October 1st 2022 and was last updated six days later."

Answered by AI

Recent research and studies

Plastic and Reconstructive SurgeryJournal

The Patient and Observer Scar Assessment Scale: A Reliable and Feasible Tool for Scar Evaluation

Draaijers, Lieneke J., Fenike R. H. Tempelman, Yvonne A. M. Botman, Wim E. Tuinebreijer, Esther Middelkoop, Robert W. Kreis, and Paul P. M. van Zuijlen. 2004. “The Patient and Observer Scar Assessment Scale: A Reliable and Feasible Tool for Scar Evaluation”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.prs.0000122207.28773.56.

JAMA DermatologyJournal

Comparison of Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis of the Face and Neck

Sklar, Lindsay R., Aunna Pourang, April W. Armstrong, Simran K. Dhaliwal, Raja K. Sivamani, and Daniel B. Eisen. 2019. “Comparison of Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis of the Face and Neck”. JAMA Dermatology. American Medical Association (AMA). doi:10.1001/jamadermatol.2018.5057.

Aesthetic Surgery JournalJournal

The Surgical Suture

Byrne, Miriam, and Al Aly. 2019. “The Surgical Suture”. Aesthetic Surgery Journal. Oxford University Press (OUP). doi:10.1093/asj/sjz036.

Archives of Dermatological ResearchJournal