Comparing suture types for better scar outcomes in patients with skin of color
Impact of Suture Type on Pigment Disturbances in Patients of Skin of Color: A Prospective, Randomized Split-wound Study
This study is testing whether dissolvable or non-dissolvable stitches lead to better-looking scars for patients with skin of color after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 3 sites (Pittsburgh, Pennsylvania and 2 other locations) |
| Trial ID | NCT05408117 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of two types of sutures—dissolvable (fast gut) and non-dissolvable (polypropylene)—on cosmetic results related to scarring and dyspigmentation in patients with skin of color. Participants undergoing standard elliptical excisions will have their wounds divided into two halves, each receiving a different suture type. Measurements of scarring and pigment changes will be taken at various intervals post-surgery. The study aims to determine which suture type yields better aesthetic outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with skin of color (NIS skin color 4 or greater) who require dermatologic surgery with a wound length of 3 cm or more.
Not a fit: Patients with high-tension closures, known allergies to suture materials, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cosmetic results and reduced pigment disturbances for patients with skin of color undergoing dermatologic surgery.
How similar studies have performed: While the specific approach of comparing these suture types in patients of skin color is novel, similar studies have shown varying success in optimizing surgical outcomes based on suture materials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania and 2 other locations
- UPMC Presbyterian — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC St. Margaret — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC Shadyside Place — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Melissa Pugliano-Mauro, MD — University of Pittsburgh Medical Center
- Study coordinator: Melissa Pugliano-Mauro, MD
- Email: puglianomauroma@upmc.edu
- Phone: 412-784-7350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.