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ScarNCT05408117

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

A study testing 5-0 Polypropylene epidermal suture and 5-0 Fast gut epidermal suture in people with Scar, run by Melissa Pugliano-Mauro at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scar
What is being tested?
5-0 Polypropylene epidermal suture and 5-0 Fast gut epidermal suture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
3 sitesUnited States
Study dates
1 Oct 2022to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Melissa Pugliano-Mauro, MD contact

412-784-7350

puglianomauroma@upmc.edu

Jeffrey M Plowey, MS, ASCP(HTL) contact

412-784-7350

ploweyjm2@upmc.edu

United States3 sites, 3 recruiting
  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

    Melissa Pugliano-Mauro, MD

    Recruiting
  • UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

    Melissa Pugliano-Mauro, MD

    Recruiting
  • UPMC Shadyside Place

    Pittsburgh, Pennsylvania, 15232

    Melissa Pugliano-Mauro, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

Subjects who consent to the study will have the following information recorded on the date of surgery: age, sex, indication for surgery, surgical site, scar length, size and type of buried intradermal suture, experience of surgeon (attending, fellow or resident), and New Immigration Scale (NIS) skin color. Basic patient medical data pertinent to wound healing/scar formation will be extracted from the medical record including history of hypertrophic scar/keloids, smoking, diabetes mellitus, and immunosuppression.

The subjects will undergo elliptical excision per standard of care. A single polyglactin 910 suture buried intradermal suture will be placed at the center of the wound. If additional buried intradermal sutures are needed, they will be placed equidistant from the center of the wound such that each side has an equivalent number of intradermal sutures. 5-0 polyglactin 910 will be used for wounds on the head and neck and 3-0 or 4-0 polyglactin 910 will be used for wounds on the trunk and extremities.

Following placement of the intradermal sutures, the subject's wound will be demarcated into halves, labeled either "A" or "B." "A" refers to the left or the superior side, and "B" refers to the right or inferior side. Prior to the study commencement, "A=fast gut" will be written on 17 index cards and "B=fast gut" will be written on 17 index cards. The index cards will be sealed in individual envelopes, shuffled to randomize, and stored securely with the study materials. At the time of surgery, the surgeon will randomly select an envelope which indicates which side will receive which suture type (either 5-0 fast absorbing gut or 5-0 polypropylene). This size of epidermal sutures will be used regardless of site of wound. The intervention will be applied sequentially with side A always being closed first. A simple running suture will be used on each half. The surgeon will aim to keep suture technique including spacing and distance from wound edge identical.

Following the procedure, a standard dressing will be applied and wound care will be discussed. Patients will be seen, as is routinely performed clinically, for suture removal for the polypropylene side in 7 days if the closure was on the head and neck and 10 days if the closure was on the trunk or extremities. Any residual component of fast gut suture that has not yet dissolved will be removed by the medical assistant or nurse so that the physician observer is blinded to which sutures were placed on which side. The following information will be collected at this suture removal visit:

  • Photo of the scar
  • Patients will perform the patient portion of the POSAS (Patient and Observer Scar Assessment Scale), a validated scale of scar cosmesis.
  • A co-investigator not present at the time of the surgical procedure will perform the physician portion of the POSAS
  • Scar width will be measured 1 cm from midline on each side of the wound. Measurements will be recorded in 0.5 mm increments.
  • Pain incurred with suture removal will be measured via a 10 point Visual Analog Scale immediately after sutures are removed, with 1 representing no pain and 10, the worst pain imaginable.

Patients will be asked to return for an in person clinic visit 3 months after surgery for subsequent scar assessment. All surgical patients, not just those involved in the research study, have follow up appointments for suture removal at 7-14 days and at 3-6 months, as per physician discretion. This time interval is the standard of care. The following information will be collected at 3 month follow up:

  • Photo of the scar
  • Patient and observer POSAS scores (again, a co-investigator not present at the time of the surgical procedure will perform the physician portion of the POSAS).
  • Dermatoscopic images of each side of the scar and of an area of normal skin. The dermatoscopic images will be used to calculate a skin hyperpigmentation index (SHI) score, a validated objective measure of skin hyperpigmentation (https://shi.skinimageanalysis.com).
  • Scar width will be measured 1 cm from midline on each side of the wound. Measurements will be recorded in 0.5 mm increments.
  • Clinical evidence of surgical site infection, wound disruption, and/or any other postsurgical complications.

Patients who fail to attend the in-person 3 month follow up visit will be contacted by telephone to complete the patient portion of the POSAS and asked to upload photos of the scar to their medical record via MyUPMC. Storage of images of the scars will occur for all patients, not just those participating in the study.

Upon completion of study visits, POSAS, SHI and other clinical data will be analyzed.

Conditions
Scar
Being tested
5-0 Polypropylene epidermal suture, 5-0 Fast gut epidermal suture
Keywords
skin of color, split-wound, polypropylene, fast gut, pigmentary disturbance
Medical subject headings
Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-0 Polypropylene epidermal sutureDevice

    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

  • 5-0 Fast gut epidermal sutureDevice

    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

Study groups in NCT05408117
Study groupRoleWhat they receive
A= left/superior half of woundExperimentalPatients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater
Receives: Device: 5-0 Polypropylene epidermal suture; Device: 5-0 Fast gut epidermal suture
B= right/inferior half of woundExperimentalPatients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater
Receives: Device: 5-0 Polypropylene epidermal suture; Device: 5-0 Fast gut epidermal suture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 3 months from procedure

  3. Skin hyperpigmentation index

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

    Measured: 3 months from procedure

Secondary outcomes (4)
  1. Scar width

    Using a ruler to measure scar width 1 cm from midline on each side of the wound. Measurements will be recorded in 0.5 mm increments.

    Measured: 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

  2. Scar width

    Using a ruler to measure scar width 1 cm from midline on each side of the wound. Measurements will be recorded in 0.5 mm increments.

    Measured: 3 months from procedure

  3. Complications

    Incidence of surgical site infection, wound dehiscence, keloids, hematomas, suture abscesses, seromas, necrosis, and suture granulomas. Greater incidence represents worse outcomes.

    Measured: 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

  4. Complications

    Incidence of surgical site infection, wound dehiscence, keloids, hematomas, suture abscesses, seromas, necrosis, and suture granulomas. Greater incidence represents worse outcomes.

    Measured: 3 months from procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start1 Oct 2022
  3. Primary completion29 Aug 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomized split-wound study
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05408117
Sponsor's protocol ID
STUDY22020176
Status last verified
Jun 2026
First submitted
30 May 2022
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

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

    PubMed 30869751
  • 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.

    PubMed 31724097
  • 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.

    PubMed 15253184
  • 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.

    PubMed 30649154
  • 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.

    PubMed 24048361

Questions about this trial

What is this clinical trial studying?

A study testing 5-0 Polypropylene epidermal suture and 5-0 Fast gut epidermal suture in people with Scar, run by Melissa Pugliano-Mauro at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa Pugliano-Mauro, MD (412-784-7350, puglianomauroma@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

POSAS (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05408117, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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