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Led by Melissa Pugliano-Mauro · Updated on 2026-06-04
34
Participants Needed
3
Research Sites
4 weeks
Total Duration
Researchers are evaluating whether dissolvable fast gut or non-dissolvable polypropylene epidermal sutures result in better cosmetic outcomes regarding pigment changes and scarring in patients with skin of color. This study uses a split-wound design where each patient receives both types of sutures on different halves of the same wound. Measurements of pigmentation and scarring will be taken at 7 or 10 days depending on the wound location, and again at 3 months after surgery. During surgery, patients will undergo standard elliptical excision with a wound length of at least 3 cm. A single buried intradermal suture will be placed centrally using polyglactin 910, with additional sutures placed symmetrically if needed. The wound will be divided into two halves, randomly assigned to receive either 5-0 fast gut or 5-0 polypropylene epidermal sutures, applied with a running technique. Sutures on the polypropylene side will be removed at 7 days for head and neck wounds, or 10 days for trunk and extremities, while residual fast gut sutures will be removed to keep observers blinded. Participants will have photos taken and scars assessed using the Patient and Observer Scar Assessment Scale POSAS at suture removal and again at 3 months post-surgery. Scar width, pain during suture removal, and skin hyperpigmentation index scores from dermatoscopic images will also be recorded. Clinical complications will be monitored, and patients unable to attend the 3-month visit will complete assessments remotely. All collected data will be analyzed to compare the cosmetic outcomes of the two suture types.
CONDITIONS
Impact of Suture Type on Pigment Disturbances in Patients of Skin of Color
M
Melissa Pugliano-Mauro, MD
J
Jeffrey M Plowey, MS, ASCP(HTL)
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Melissa Pugliano-Mauro
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Polypropylene Suture | Fast Gut Suture |
|---|---|---|
| What it is | A non-absorbable, monofilament 5-0 polypropylene suture used for epidermal closure on one half of the dermatologic excision wound. | A rapidly absorbable plain gut 5-0 suture applied for epidermal closure on the other half of the excision wound within the same patient. |
| Role in trial | Investigational closure method for one assigned half; outcomes such as pigmentation, scar width, and POSAS are measured on this side and compared directly with the opposite suture. | Direct comparator closure method for the other assigned half; pigmentation, scar width, and patient/observer scores measured on this side serve as internal control within each participant. |
| Primary use | Epidermal wound closure after dermatologic excisions (benign or malignant) in adults of skin of color; aimed to reduce pigment disturbance and optimize scar quality. | Epidermal wound closure in similar excision procedures for the same population; compared for impact on pigment changes and scarring. |
| How it is given or performed | Suture is manually applied as a running simple epidermal closure along the assigned half of the surgical incision. Suture remains in place until suture removal at 7–10 days (timing varies by site). | Suture is placed as a running simple epidermal closure on the assigned half of the wound. Suture is absorbable and does not require removal; it degrades naturally post-procedure. |
| Evidence status | High-certainty evidence from randomized trials and reviews supports polypropylene suture as a reliable epidermal closure option, though differences in pigment disturbance for diverse skin types remain understudied. Prior split-wound randomized trials show comparable cosmetic outcomes between polypropylene and fast gut sutures in general populations, but evidence specifically in skin of color is limited. | Similar level of evidence exists for fast gut suture as an epidermal closure technique, with randomized direct intra-individual comparison showing generally comparable scarring, pigment, and complication rates. Specific impact on pigment disturbance in adults with darker skin requires further validation, as current evidence predominantly reflects lighter skin types. |
| Important limitations | Main limitation is that although polypropylene suture is established for cutaneous closure, evidence regarding pigment alteration and optimal cosmetic endpoints in adults with darker skin types is sparse. The technical difference in absorption (requires manual removal) may influence patient experience. | There is limited published research on pigment impact in skin of color, and existing studies focus largely on lighter skin types. Gut suture is absorbable, which may improve convenience but could affect wound healing differently in diverse pigment backgrounds. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Day of surgery
Participants undergo dermatologic surgery with a standard elliptical excision and receive two different types of epidermal sutures on each half of their wound as part of the study intervention.
1 in-person surgery visit
Duration - 7 to 10 days after surgery depending on wound location
Participants have sutures removed and undergo scar assessment including photos, scar scoring, scar width measurement, and pain evaluation shortly after surgery.
1 in-person suture removal visit
Duration - 3 months after surgery
Participants return for scar evaluation including photos, scar scoring, dermatoscopic imaging, scar width measurement, and clinical assessment of wound healing and complications.
1 in-person follow-up visit with possible telephone follow-up if in-person visit is missed
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
