Suture Types for Scarring in Darker Skin Tones

Recruiting at 2 trial locations

Overseen By Jeffrey M Plowey, MS, ASCP(HTL)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Melissa Pugliano-Mauro

Disqualifiers: High-tension closures, Suture allergy, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of suture—dissolvable or non-dissolvable—leads to better healing with less scarring and discoloration in people with darker skin tones. Participants will receive two different types of stitches, including the Fast gut epidermal suture (a dissolvable suture), applied to different parts of their surgical wound to compare results. This study is ideal for adults with darker skin undergoing dermatologic surgery involving a specific type of skin removal procedure. As an unphased trial, it offers participants the opportunity to contribute to important research that could improve surgical outcomes for people with darker skin tones.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these suture types are safe for patients with skin of color?

Previous studies have shown that fast-absorbing gut sutures are well-tolerated and cause little irritation. They dissolve quickly, eliminating the need for a return visit to the doctor for removal. This convenience reduces the risk of infection from stitch removal.

In contrast, polypropylene sutures do not dissolve and are commonly used in skin surgeries. They move smoothly through the skin and cause minimal irritation. Some reports mention negative reactions, where the body does not respond well to the material, but these reactions are uncommon.

Both types of sutures have been used safely in surgeries, and they are generally considered safe. If a trial involves these sutures, the risk remains low, but it is important to watch for any unusual changes and report them to a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different suture materials affect scarring in people with darker skin tones. Unlike the standard sutures usually used in surgeries, which often include nylon or silk, this trial compares fast gut and polypropylene sutures specifically for their impact on scarring. The unique focus here is on minimizing scars, which can be more prominent in people with darker skin due to increased melanin. By understanding which suture type works best, the trial aims to improve cosmetic outcomes for a diverse range of patients.

What evidence suggests that these suture types are effective for reducing scarring in darker skin tones?

This trial will compare two types of sutures for scarring in darker skin tones. Participants will receive either fast-absorbing gut sutures or polypropylene sutures. Research has shown that fast-absorbing stitches dissolve quickly, eliminating the need for extra visits to remove them. However, they might cause swelling, particularly in individuals with darker skin. In contrast, polypropylene stitches do not dissolve and are less likely to cause swelling, which can enhance scar healing. Studies have found that polypropylene stitches might improve scar appearance by reducing changes in skin color. Both types of stitches aim to enhance scar appearance, but they achieve this in different ways. ^{1 3 6 7 8}

Who Is on the Research Team?

Melissa Pugliano-Mauro, MD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with skin color NIS scale of 4 or higher, undergoing dermatologic surgery needing at least a 3 cm incision. They must be able to consent, return for follow-up after 3 months, and can have benign or malignant lesions. It's not for those allergic to suture materials, pregnant women, or cases requiring high-tension closures.

Inclusion Criteria

Able to give informed consent

I can come back for a check-up in 3 months.

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

Known allergy to suture material

My wound cannot be closed with simple stitches.

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Assessment

Participants undergo standard elliptical excisions and initial suture placement. Initial assessments and data collection occur on the date of surgery.

1 day

1 visit (in-person)

Suture Removal and Assessment

Suture removal and initial scar assessment, including POSAS and pain measurement, occur 7-10 days post-surgery.

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for scar assessment and complications, including POSAS, SHI, and other clinical evaluations, 3 months post-surgery.

3 months

1 visit (in-person), with phone follow-up if missed

What Are the Treatments Tested in This Trial?

Interventions

• Fast gut epidermal suture
• Polypropylene epidermal suture

Trial Overview The study compares dissolvable (fast gut) versus non-dissolvable (polypropylene) sutures in patients of darker skin tones to see which causes less scarring and pigment changes post-surgery. Each patient will receive both types on different halves of the same wound.

How Is the Trial Designed?

Group I: B= right/inferior half of wound Experimental Treatment 2 Interventions

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

Group II: A= left/superior half of wound Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Melissa Pugliano-Mauro

Lead Sponsor

Trials

3

Recruited

90+

Published Research Related to This Trial

In a study involving 14 patients who underwent Mohs micrographic surgery, both cyanoacrylate topical adhesive and fast absorbing gut sutures produced similar cosmetic outcomes for facial wound closure, indicating that either method can be effectively used without compromising aesthetics.

While most patients showed no preference for the closure technique, those who did preferred cyanoacrylate, suggesting it may be favored for its convenience, despite its potential limitations in achieving optimal cosmetic results for longer or forehead wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast Absorbing Gut Suture versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery. Kim, J., Singh Maan, H., Cool, AJ., et al.[2022]

In a randomized trial comparing 5-0 polypropylene (PP) sutures to 5-0 fast absorbing plain (FG) gut sutures for wound closure, PP showed significantly better cosmetic outcomes, with lower scores on the patient observer scar assessment scale (POSAS) (10.26 for PP vs 12.74 for FG, p < 0.001).

Patients reported a significantly better overall opinion of their scars with PP compared to FG (2.41 vs 3.14, p = 0.043), indicating that PP may be the preferred choice for improved scar appearance after linear cutaneous surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-0 Polypropylene versus 5-0 fast absorbing plain gut for cutaneous wound closure: a randomized evaluator blind trial. Eisen, DB., Zhuang, AR., Hasan, A., et al.[2020]

In a study of 44 patients comparing 2-octylcyanoacrylate (OCA) and 5-0 fast-absorbing gut suture (FG) for wound closure, both methods resulted in similar overall scar appearance as assessed by patients and blinded observers.

However, scars closed with OCA showed significantly worse pigmentation compared to those closed with FG, indicating a potential drawback in cosmetic outcomes despite similar overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 2-Octylcyanoacrylate Versus 5-0 Fast-Absorbing Gut During Linear Wound Closures and the Effect on Wound Cosmesis. Zhuang, AR., Beroukhim, K., Armstrong, AW., et al.[2021]

In a study comparing 6-0 and 5-0 Fast Absorbing Gut sutures for linear cutaneous surgery on the head and neck, no significant difference in scar appearance was found, indicating that both suture sizes yield similar cosmetic outcomes.

The study also showed no significant difference in complication rates between the two suture sizes, suggesting that both are equally safe for use in this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 5-0 Fast Absorbing Gut versus 6-0 Fast Absorbing Gut during cutaneous wound closure on the head and neck: A randomized evaluator-blinded split-wound comparative effectiveness trial. Pourang, A., Crispin, MK., Clark, AK., et al.[2019]

The study found that using the faster-absorbing polyglytone 6211 sutures resulted in fewer cases of extrusion compared to the slower-absorbing poliglecaprone 25 sutures, indicating a potential safety advantage.

There were no significant differences in complications such as granuloma formation, infection, or scar aesthetics between the two suture types at the 12-week follow-up, suggesting that faster absorption does not compromise overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind controlled trial of polyglytone 6211 versus poliglecaprone 25 for use in body contouring. Naghshineh, N., Ota, KS., Tang, L., et al.[2010]

Using fast-absorbing gut sutures during Mohs micrographic surgery allowed for fewer in-person follow-ups without increasing postoperative complications, which is particularly beneficial during the COVID-19 pandemic.

However, for patients with skin of color, opting for less inflammatory nonabsorbable sutures may lead to better cosmetic outcomes by reducing postinflammatory hyperpigmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suture Selection to Minimize Postoperative Postinflammatory Hyperpigmentation in Patients With Skin of Color During Mohs Micrographic Surgery. Bravo, CG., Negbenebor, NA.[2023]

In a study involving 105 patients who underwent Mohs micrographic surgery, both rapidly absorbable polyglactin 910 and nonabsorbable nylon sutures produced similar facial scar appearances at 6 months post-surgery.

The evaluation of scar appearance showed no significant differences in scores across various assessment scales, indicating that either suture type can be effectively used for epidermal closure without impacting scar quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photographic assessment of postsurgical facial scars epidermally sutured with rapidly absorbable polyglactin 910 or nylon: A randomized clinical trial. Moran, B., Humphrey, S., Seal, A., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38850366/

Fast absorbing gut sutures in dermatologic surgery Fast gut cutaneous sutures have become more prominent due to their low tissue reactivity, rapid absorption, and elimination of suture removal visits.

2. withpower.com withpower.com/trial/phase-scarring-5-2022-74da1

Suture Types for Scarring in Darker Skin Tones Fast absorbing gut sutures are generally safe but can cause inflammation, especially in people with darker skin tones. Polypropylene sutures are nonabsorbable ...

3. jnjmedtech.com jnjmedtech.com/en-US/product/fast-absorbing-plain-gut-suture

Fast Absorbing Surgical Gut Suture (Plain) - J&J MedTech Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep.

4. jaad.org jaad.org/article/S0190-9622(21)00838-0/pdf

Suture materials and techniques for optimal cutaneous ... We performed a systematic review of the literature on how suture materials and techniques affect scar cosmesis. A primary literature search for peer-reviewed.

5. academicworks.medicine.hofstra.edu academicworks.medicine.hofstra.edu/cgi/viewcontent.cgi?article=7579&context=publications

5-0 Polypropylene versus 5-0 fast absorbing plain gut for ... Objectives: To determine whether the use of PP during layered repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with FG ...

6. ethicon.com ethicon.com/na/epc/code/1915g

1915G - Ethicon Surgical Technologies As an absorbable suture, surgical gut may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of infected ...

7. anwresidency.com anwresidency.com/simulation/guide/resources/Ethicon_Wound_Closure_manual.pdf

WOUND CLOSURE MANUAL ;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;; Fast absorbing surgical gut sutures are intended for dermal (skin) suturing only. They should be utilized only for external knot tying procedures. ACTIONS.

8. jnjmedtech.com jnjmedtech.com/en-US/product/surgical-plain-gut-suture

Surgical Plain Gut Suture by ETHICON™ | J&J MedTech An absorbable, sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or ...