3M Topical Tissue Adhesive for Cuts

(Lublin Trial)

Not currently recruiting at 4 trial locations

Overseen By Kelly Bartsh, MN, RN

Age: Any Age

Sex:

Trial Phase: Academic

Sponsor: Solventum US LLC

Disqualifiers: Pregnancy, Peripheral vascular disease, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two skin adhesives to determine which is more effective for closing cuts and surgical incisions. One group will use the 3M Topical Tissue Adhesive (Nexcare No Sting Liquid Bandage), while the other will use Histoacryl® Blue Topical Skin Adhesive. The goal is to identify which adhesive promotes better and faster wound healing. Individuals with a single cut or surgical incision, such as those from minor surgeries, that is 10 cm or shorter and can be closed with glue may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the 3M Topical Tissue Adhesive is generally safe for use on the skin. Although detailed clinical data remains limited, it resembles other adhesive products like the Nexcare Liquid Bandage Spray. This spray forms a protective layer over cuts and does not sting upon application.

For Histoacryl® Blue Topical Skin Adhesive, studies have shown that most people tolerate it well. It is used to close wounds and is usually safe, with only minor skin reactions reported in some cases.

Both products are designed for use on the skin to keep wounds clean and protected. Available evidence suggests they are safe, but monitoring for any signs of skin irritation is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The 3M Topical Tissue Adhesive is unique because it offers a potentially faster and more convenient option for closing cuts compared to traditional sutures and staples. Unlike these standard methods, which can be time-consuming and require follow-up visits for removal, the 3M adhesive provides a quick and non-invasive way to close wounds. This adhesive works by forming a strong bond that seals the wound, reducing the risk of infection and potentially improving cosmetic outcomes. Researchers are excited about its ease of use and the possibility of reducing the burden on healthcare facilities by minimizing the need for additional medical appointments.

What evidence suggests that this trial's treatments could be effective for cuts?

Research has shown that 3M Topical Tissue Adhesive, which participants in this trial may receive, helps wounds heal by creating a protective, waterproof layer on the skin. This clear shield keeps out water and dirt, making it useful for cuts. Studies have found that this layer protects against moisture and rubbing, aiding in better wound healing. The adhesive also allows air to reach the skin, which is important for healing.

Histoacryl® Blue Topical Skin Adhesive is another product studied in this trial. It effectively seals wounds, closes cuts quickly, and can reduce the need for stitches. Both treatments assist with wound care, but each has unique features that might make one more suitable depending on specific needs. ^{2 6 7 8 9}

Who Is on the Research Team?

Sher-ree Beekman

Principal Investigator

Solventum

Are You a Good Fit for This Trial?

This trial is for adults over 22 with low tension surgical incisions or clean, superficial lacerations that can be easily closed. Participants must understand the study and agree to follow its rules and attend all visits. It's not suitable for those who don't meet these wound criteria.

Inclusion Criteria

Subject or Subject's legally authorized representative can provide informed consent

I can attend all study visits and follow study rules.

I have a cut or up to 4 surgical cuts, each no longer than 10 cm, suitable for special glue treatment.

Exclusion Criteria

Subject has a positive pregnancy test within 48 hours prior to randomization at Day 0 or is lactating prior to randomization at Day 0

Subject has a known hypersensitivity or allergy to any of the components of study products (eg, polyoxamides or cyanoacrylates)

Subject is concurrently participating in or was enrolled in another interventional clinical study within 30 days of randomization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 10 days

1 visit (in-person)

Treatment

Application of tissue adhesive on Day 0 for closure of lacerations or incisions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

2 visits (in-person) at 10 days and 30 days

What Are the Treatments Tested in This Trial?

Interventions

• 3M Topical Tissue Adhesive
• Histoacryl® Blue Topical Skin Adhesive

Trial Overview The study compares two types of skin adhesives: 3M™ Topical Tissue Adhesive and Histoacryl® Blue. Patients with qualifying wounds are randomly chosen to receive one of these treatments, with their healing observed at 10 and 30 days post-application.

How Is the Trial Designed?

Group I: Investigational Topical Tissue Adhesive Experimental Treatment 1 Intervention

3M Topical Tissue Adhesive

Group II: Control Topical Tissue Adhesive Active Control 1 Intervention

Histoacryl® Blue Topical Skin Adhesive

3M Topical Tissue Adhesive is already approved in United States for the following indications:

Approved in United States as 3M Topical Tissue Adhesive for:

• Closure of lacerations and incisions

Who Is Running the Clinical Trial?

Solventum US LLC

Lead Sponsor

Trials

68

Recruited

10,600+

Bryan Hanson

Solventum US LLC

Chief Executive Officer since 2024

Bachelor's degree in Business Administration from Indiana University

Dr. Ryan Egeland

Solventum US LLC

Chief Medical Officer

MD, trained in Plastic and Reconstructive Surgery

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+

3M

Industry Sponsor

Trials

160

Recruited

31,600+

Dr. John Banovetz

3M

Chief Medical Officer since 2017

PhD in Inorganic Chemistry from Stanford University, Bachelor's degree in Chemistry from Hamline University

William 'Bill' Brown

3M

Chief Executive Officer

Bachelor's and Master's degrees in Mechanical Engineering from Villanova University, MBA from The Wharton School, University of Pennsylvania

Published Research Related to This Trial

3M Health Care has introduced no sting barrier film applicators designed to protect vulnerable skin in incontinent patients and those using aggressive adhesive products.

These new applicators offer a pain-free application method, improving comfort for patients compared to traditional ointments and alcohol-based products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3M Cavilon No Sting Barrier Film in the protection of vulnerable skin. Williams, C.[2004]

Medical adhesive-related skin injuries are common but often overlooked, affecting patients of all ages and leading to increased healthcare costs and decreased quality of life.

A consensus panel of 23 experts has established best practices for preventing and treating these injuries, highlighting the need for better guidance on adhesive selection, application, and removal techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. McNichol, L., Lund, C., Rosen, T., et al.[2016]

Histoacryl Blue (HAB) is an effective alternative to traditional sutures for laceration repair in children, showing comparable cosmetic outcomes and significantly less pain as reported by parents.

The use of HAB reduced the repair time to a median of 7 minutes compared to 17 minutes for sutures, making it a more efficient option for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laceration repair using a tissue adhesive in a children's emergency department. Bruns, TB., Simon, HK., McLario, DJ., et al.[2013]

In a study involving 81 children with facial lacerations, Histoacryl Blue was found to be a faster (7.9 minutes vs. 15.6 minutes) and less painful (24.7 mm vs. 43.7 mm on a pain scale) alternative to sutures for laceration repair.

Cosmetic outcomes were similar between Histoacryl Blue and sutures, with no significant differences in appearance scores, indicating that Histoacryl Blue is an effective option for pediatric facial lacerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial comparing a tissue adhesive with suturing in the repair of pediatric facial lacerations. Quinn, JV., Drzewiecki, A., Li, MM., et al.[2022]

Tissue adhesive glue is significantly faster to apply than sutures for repairing simple lacerations in children, taking only 0-2 minutes compared to 6-10 minutes for sutures.

Both methods resulted in similar cosmetic outcomes after 3 and 12 months, but glue was rated as less distressing by doctors, nurses, and parents, indicating it may be a more comfortable option for young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial of histoacryl blue tissue adhesive glue versus suturing in the repair of paediatric lacerations. Barnett, P., Jarman, FC., Goodge, J., et al.[2019]

Butyl-2-cyanoacrylate (Histoacryl) is a promising tissue adhesive that shows low tissue reactivity and toxicity, making it suitable for surgical applications, particularly in middle ear surgery.

In a clinical trial involving 100 patients, Histoacryl demonstrated no significant adverse effects on wound healing, graft rejection, or infection over a six-month period, suggesting it may be a safer alternative to traditional sutures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histoacryl. Its use in aesthetic facial plastic surgery. Kamer, FM., Joseph, JH.[2022]

Medical adhesive-related skin injuries are common but often overlooked, affecting patients of all ages and leading to increased healthcare costs and decreased quality of life.

A consensus panel of 23 experts has established best practices for preventing and treating these injuries, highlighting the need for better guidance on adhesive selection, application, and removal techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. McNichol, L., Lund, C., Rosen, T., et al.[2022]

A retrospective study of 1,098 pediatric patients showed that using N-butyl-2-cyanoacrylate for closing low-tension surgical incisions resulted in a low complication rate, with only 5.5% experiencing redness or tenderness and 1.1% having wound dehiscence.

The cosmetic outcomes were rated highly by families, with an average satisfaction score of 4.73 out of 5, indicating that this tissue adhesive is not only safe but also effective for aesthetic results in pediatric surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of N-butyl-2-cyanoacrylate in elective surgical incisions--longterm outcomes. Amiel, GE., Sukhotnik, I., Kawar, B., et al.[2019]

Histoacryl, a blue tissue adhesive introduced by Davis and Geek, serves as a gentle alternative to stitches for treating minor skin wounds in children, eliminating the need for anaesthetic and follow-up visits for stitch removal.

This adhesive not only reduces trauma for young patients and their parents but also eases the process for medical staff, making it a beneficial option in accident and emergency departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacement for sutures. [2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9845128/

Spray Film-Forming systems as promising topical in situ Systems Provides adhesion, allows adhesion of tapes, bandages and attachments. Transparent, permeable for air. After application, a thin, non-sticky, elastic coating is ...

2. nexcare.com nexcare.com/3M/en_US/p/d/b00016071/

Nexcare Liquid Bandage Spray | 3M United States Nexcare No Sting Liquid Bandage Spray creates a waterproof clear shield that dries in about 30 seconds. The protective coating keeps out water and dirt.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7950487/

A laboratory comparison between two liquid skin barrier ... The purpose of this experimental study was to investigate the ability of a cyanoacrylate polymer film to protect human skin against moisture and abrasion.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666142X22000170

Prevention of medical adhesive-related skin injury during ... Effect of a water-based no-sting, protective barrier formulation and a solvent-containing similar formulation on skin protection from medical adhesive trauma.

5. multimedia.3m.com multimedia.3m.com/mws/media/2182804O/3m-advanced-wound-care-skin-integrity-solutions-portfolio-catalogue-uk-and-ireland.pdf

Advanced wound care and skin integrity solutions. 3M have a variety of solutions to help treat these indications and create the optimum wound healing environment. Suitable for all exudate levels. Manage exudate.

6. multimedia.3m.com multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8l00xMxtUlYt1Nv70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet SECTION 1 Response: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Do NOT induce vomiting.

7. multimedia.3m.com multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSu9n_zu8l00xMxtUlYt1Nv70k17zHvu9lxtD7xt1evSSSSSS-

Nexcare™ Liquid Bandage Spray (LBS118-03, LBS-118 ... SDS (US OSHA). See Safety Data Sheet (SDS) for hazard and other regulatory data. California Proposition 65.

8. sdsmanager.com sdsmanager.com/safety-data-sheet/3m-3m-nexcare-no-sting-liquid-bandage-io-cat-118-03-en/

3M Nexcare No Sting Liquid Bandage (IO) Cat. 118-03 Download Safety Data Sheet for 3m 3M Nexcare No Sting Liquid Bandage (IO) Cat. 118-03.

9. 3m.com 3m.com/3M/en_LB/p/d/v101461674/

Nexcare™ Liquid Bandage Spray LBS-118, 18 ml, 1/Pack Nexcare™ Liquid bandage spray provides a innovative skin shield that covers minor cuts and scrapes. Product is alcohol-free with no stinging on application.