Suture Types for Scarring in Darker Skin Tones

Recruiting at 2 trial locations

Overseen By Melissa Pugliano-Mauro, MD

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

Trial Summary

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 data supports the effectiveness of the treatment Fast gut epidermal suture, Fast Absorbing Gut Suture, Fast Absorbing Plain Gut Suture, Ethicon Fast Absorbing Surgical Plain Gut Suture, Polypropylene epidermal suture, Prolene for scarring in darker skin tones?

Research suggests that fast-absorbing gut sutures can reduce the need for follow-up visits without increasing complications, but they may cause more inflammation in darker skin, potentially affecting cosmetic outcomes. Nonabsorbable sutures like polypropylene might offer better cosmetic results by causing less inflammation. ^{1 2 3 4 5}

Is it safe to use fast absorbing gut sutures or polypropylene sutures in humans?

Fast absorbing gut sutures are generally safe but can cause inflammation, especially in people with darker skin tones. Polypropylene sutures are nonabsorbable and may lead to better cosmetic outcomes with fewer complications. ^{1 2 3 6 7}

How does the suture type treatment differ for scarring in darker skin tones?

This treatment focuses on using nonabsorbable sutures, like polypropylene, which are less inflammatory compared to absorbable sutures like fast-absorbing gut. This is important for patients with darker skin tones as it can help minimize postinflammatory hyperpigmentation (darkening of the skin after inflammation) and improve cosmetic outcomes. ^{1 2 3 5 7}

What is the purpose of this trial?

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.

Research Team

Melissa Pugliano-Mauro, MD

Principal Investigator

University of Pittsburgh Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

5-0 Polypropylene versus 5-0 fast absorbing plain gut for cutaneous wound closure: a randomized evaluator blind trial. [2020]

2. United States 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Fast Absorbing Gut Suture versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A double-blind controlled trial of polyglytone 6211 versus poliglecaprone 25 for use in body contouring. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Photographic assessment of postsurgical facial scars epidermally sutured with rapidly absorbable polyglactin 910 or nylon: A randomized clinical trial. [2021]