An interventional study of 5-0 Polypropylene epidermal suture and 5-0 Fast gut epidermal suture in Scar, sponsored by Melissa Pugliano-Mauro. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Melissa Pugliano-Mauro · Not applicable, Interventional, and Treatment
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.
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:
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:
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.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's planned enrollment of 34 is below the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Melissa Pugliano-Mauro is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
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
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.
Time frame: 3 months from procedure
Skin hyperpigmentation index
1-4 scale, higher value indicates worse outcomes (greater dyspigmentation), lower values represent better outcomes
Time frame: 3 months from procedure
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.
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
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.
Time frame: 3 months from procedure
Complications
Incidence of surgical site infection, wound dehiscence, keloids, hematomas, suture abscesses, seromas, necrosis, and suture granulomas. Greater incidence represents worse outcomes.
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
Complications
Incidence of surgical site infection, wound dehiscence, keloids, hematomas, suture abscesses, seromas, necrosis, and suture granulomas. Greater incidence represents worse outcomes.
Time frame: 3 months from procedure
Plan to share: No
Started Oct 2022 (actual). Primary completion is estimated for Aug 2027, 58 months after the start.
Of 173 non-industry interventional studies with no phase under Cicatrix, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 58 months is above that.
Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Melissa Pugliano-Mauro