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

NCT05408117 | Recruiting DMC FDA Device

• 1 other identifier: STUDY22020176
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• POSAS

  Patient and Observer Scar Assessment Scale (POSAS) outcome (6-60 scale). 6 subscales (which assess scar pain, itch, color, stiffness, thickness, and irregularity) comprise the POSAS measure and each are measured 1-10. Subscales will be summed to get a total score out of 60. Higher values represent worse outcomes.

  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

  Patient and Observer Scar Assessment Scale (POSAS) outcome (6-60 scale). 6 subscales (which assess scar pain, itch, color, stiffness, thickness, and irregularity) comprise the POSAS measure and each are measured 1-10. Subscales will be summed to get a total score out of 60. Higher values represent worse outcomes.

  3 months from procedure

• Skin hyperpigmentation index

  1-4 scale, higher value indicates worse outcomes (greater dyspigmentation), lower values represent better outcomes

  3 months from procedure

Secondary Outcomes (4)

• Scar width

  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

• Scar width

  3 months from procedure

• Complications

  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

• Complications

  3 months from procedure

Study Arms (2)

A= left/superior half of wound

EXPERIMENTAL

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

Device: 5-0 Polypropylene epidermal suture; Device: 5-0 Fast gut epidermal suture

B= right/inferior half of wound

EXPERIMENTAL

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

Device: 5-0 Polypropylene epidermal suture; Device: 5-0 Fast gut epidermal suture

Interventions

5-0 Polypropylene epidermal suture DEVICE

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

A= left/superior half of wound; B= right/inferior half of wound

5-0 Fast gut epidermal suture DEVICE

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

A= left/superior half of wound; B= right/inferior half of wound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to give informed consent
• Able to return for 3 month follow up
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Melissa Pugliano-Mauro: lead

Study Sites (3)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

RECRUITING

UPMC Shadyside Place

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Related Publications (5)

• Byrne M, Aly A. The Surgical Suture. Aesthet Surg J. 2019 Mar 14;39(Suppl_2):S67-S72. doi: 10.1093/asj/sjz036.

  PMID: 30869751 BACKGROUND

• Eisen DB, Zhuang AR, Hasan A, Sharon VR, Bang H, Crispin MK. 5-0 Polypropylene versus 5-0 fast absorbing plain gut for cutaneous wound closure: a randomized evaluator blind trial. Arch Dermatol Res. 2020 Apr;312(3):179-185. doi: 10.1007/s00403-019-02009-5. Epub 2019 Nov 13.

  PMID: 31724097 BACKGROUND

• Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.

  PMID: 15253184 BACKGROUND

• Sklar LR, Pourang A, Armstrong AW, Dhaliwal SK, Sivamani RK, Eisen DB. 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. JAMA Dermatol. 2019 Mar 1;155(3):321-326. doi: 10.1001/jamadermatol.2018.5057.

  PMID: 30649154 BACKGROUND

• Eilers S, Bach DQ, Gaber R, Blatt H, Guevara Y, Nitsche K, Kundu RV, Robinson JK. Accuracy of self-report in assessing Fitzpatrick skin phototypes I through VI. JAMA Dermatol. 2013 Nov;149(11):1289-94. doi: 10.1001/jamadermatol.2013.6101.

  PMID: 24048361 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Pugliano-Mauro, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Pugliano-Mauro, MD

CONTACT

412-784-7350; puglianomauroma@upmc.edu

Jeffrey M Plowey, MS, ASCP(HTL)

CONTACT

412-784-7350; ploweyjm2@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sutures will be removed in their entirety before scar assessment by a co-investigator such that the outcomes assessor is blinded to which suture was used on which side of the scar.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: prospective, randomized split-wound study

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 7, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)