3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and Incisions

NCT06217081 | Terminated Results

• 2 other identifiers: EM-05-01502959MDW-23000524-A
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue Adhesive or Histoacryl® Blue Topical Skin Adhesive with follow-up visits at 10 days and 30 days after application of tissue adhesive.

Conditions

Trauma-related Wound; Surgical Incision; Surgical Wound; Laceration

Outcome Measures

Primary Outcomes (1)

• Apposition of Skin Edges

  Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive

  10 days

Secondary Outcomes (2)

• Tissue Adhesive Remaining

  10 days

• Apposition of Skin Edges

  30 days

Other Outcomes (1)

• Vancouver Scar Scale

  30 days

Study Arms (2)

Investigational Topical Tissue Adhesive

EXPERIMENTAL

3M Topical Tissue Adhesive

Device: 3M Topical Tissue Adhesive

Control Topical Tissue Adhesive

ACTIVE COMPARATOR

Histoacryl® Blue Topical Skin Adhesive

Device: Histoacryl® Blue Topical Skin Adhesive

Interventions

3M Topical Tissue Adhesive DEVICE

Application of investigational topical tissue adhesive to trauma laceration or surgical incision.

Investigational Topical Tissue Adhesive

Histoacryl® Blue Topical Skin Adhesive DEVICE

Application of control topical tissue adhesive to trauma laceration or surgical incision.

Control Topical Tissue Adhesive

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 22 years of age on the date of informed consent
• Subject or Subject's legally authorized representative can provide informed consent
• Subject is willing and able to attend all scheduled study visits and abide by all study restrictions
• Subject has a single laceration that is ≤ 100 mm (10.0 cm) in length or up to 4 surgical incision(s), each ≤ 100 mm (10.0 cm) in length, defined as Class I or Class II wound(s), in which the use of a tissue adhesive (in combination with but not replacing deep dermal sutures, if applicable) is appropriate, including the following:
• surgical incision from a minimally invasive surgery
• low tension incision
• superficial laceration
• clean, traumatic laceration with edges that can be easily approximated

You may not qualify if:

• 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 is found to have any of the following before randomization:
• a known peripheral vascular disease
• a history of hypertrophic scarring and/or keloids
• any Class III or Class IV wounds
• uncontrolled diabetes mellitus (DM), defined as HbA1C ≥ 10% within 90 days before screening. If HbA1C data is unavailable or the Subject presents in an emergency situation, uncontrolled DM will be defined as blood glucose ≥ 250 mg/dL
• a known blood clotting disorder
• immunocompromised
• a known systemic or local bacterial, viral, or fungal infection
• critical injury
• condition(s) that in the opinion of the Investigator will impact study results (eg, hemophilia or autoimmune disorder) or the ability of the Subject to remain compliant with study procedures, study restrictions, and/or visits
• 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
• Subject has a laceration or incision that is \> 100 mm (10 cm) in length
• Subject has any incision that is within 5 cm of any adjacent incision

Sponsors & Collaborators

• Solventum US LLC: lead
• United States Department of Defense: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• 3M: collaborator

MeSH Terms

Conditions

Surgical Wound; Lacerations

Interventions

Tissue Adhesives

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Outcome data were not collected/analyzed because the study was terminated early by the Sponsor due to safety concerns, including the frequency of adverse events. Following early termination, wound images required for independent assessor evaluation of endpoints were not provided, and the prespecified efficacy/performance analyses were not conducted. Therefore, outcome analyses were not performed, and the study results are limited to safety endpoints only.

Results Point of Contact

• Title: Tracy Swanson, Clinical Project Manager
• Organization: Solventum

tswanson@solventum.com

6125417752

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 22, 2024
• Study Start: October 28, 2024
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: July 27, 2026
• Results First Posted: July 27, 2026

Record last verified: 2026-06