3M Topical Tissue Adhesive for Cuts

(Lublin Trial)

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

452 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

What data supports the effectiveness of the treatment 3M Topical Tissue Adhesive for cuts?

Research shows that Histoacryl Blue, a component of the treatment, is effective for closing minor skin wounds in children, providing a gentle alternative to stitches without the need for anesthesia. It is also preferred for pediatric facial lacerations due to its good cosmetic outcomes and minimal complications. ^{1 2 3 4 5}

Is 3M Topical Tissue Adhesive safe for use in humans?

3M Topical Tissue Adhesive, also known as Histoacryl, is generally considered safe for use in humans, especially for minor skin wounds. It is used as an alternative to stitches, reducing the need for anesthesia and follow-up visits, which can lessen trauma for patients. However, improper application or removal can cause skin injuries, so proper technique is important to ensure safety. ^{1 4 5 6 7}

How is the treatment 3M Topical Tissue Adhesive different from other treatments for cuts?

3M Topical Tissue Adhesive, also known as Histoacryl Blue, is unique because it acts as a 'tissue glue' that can replace stitches for minor skin wounds, especially in children. It eliminates the need for anesthesia and follow-up visits to remove stitches, reducing trauma for patients and simplifying the treatment process. ^{1 3 4 8 9}

Research Team

Sher-ree Beekman

Principal Investigator

Solventum

Eligibility Criteria

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

I can attend all study visits and follow study rules.

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

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)

I have a cut or surgical cut longer than 10 cm.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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.[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.[2016]

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]

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]

References

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

Laceration repair using a tissue adhesive in a children's emergency department. [2013]

2. Australia pubmed.ncbi.nlm.nih.gov

Randomised trial of histoacryl blue tissue adhesive glue versus suturing in the repair of paediatric lacerations. [2019]

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

Use of N-butyl-2-cyanoacrylate in elective surgical incisions--longterm outcomes. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Replacement for sutures. [2019]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2022]

7. United States 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. [2016]

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

A randomized, controlled trial comparing a tissue adhesive with suturing in the repair of pediatric facial lacerations. [2022]

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

Histoacryl. Its use in aesthetic facial plastic surgery. [2022]