RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multi-Center, Prospective, Open-label, Randomized, Non-inferiority Study of 3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions

Quick Facts

Study Start:2024-10-28

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06217081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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 * Subject has one of the following: * a "burst" or stellate laceration * wound with exposed bone * wound with suspected skin edge ischemia due to extensive undermining * wound requiring drain(s) * wound requiring a conventional closure method (eg, subcuticular/intradermal suture, staples, adhesive strips) OR subcuticular stitch placement for enhanced wound support (ie, to further minimize tension) * Subject has a wound with any of the following etiologies: * human or animal bite * prolonged pressure (ie, decubitus) * Subject has a wound in any of the following anatomical locations: * on mucosal surfaces or across mucocutaneous junctions (eg, oral cavity, lips) * in or around the eyes * an anatomical area that is under tension or over a joint * on an area that may be regularly exposed to body fluids or with dense natural hair present (eg, scalp)

Inclusion Criteria

Exclusion Criteria

* 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

* 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
* Subject has one of the following:
* a "burst" or stellate laceration
* wound with exposed bone
* wound with suspected skin edge ischemia due to extensive undermining
* wound requiring drain(s)
* wound requiring a conventional closure method (eg, subcuticular/intradermal suture, staples, adhesive strips) OR subcuticular stitch placement for enhanced wound support (ie, to further minimize tension)
* Subject has a wound with any of the following etiologies:
* human or animal bite
* prolonged pressure (ie, decubitus)
* Subject has a wound in any of the following anatomical locations:
* on mucosal surfaces or across mucocutaneous junctions (eg, oral cavity, lips)
* in or around the eyes
* an anatomical area that is under tension or over a joint
* on an area that may be regularly exposed to body fluids or with dense natural hair present (eg, scalp)

Contacts and Locations

Study Contact

Doug Flashinski, MN, RN

CONTACT

6127992643

dflashinski@solventum.com

Principal Investigator

Sher-ree Beekman

STUDY_DIRECTOR

Solventum

Study Locations (Sites)

Hennepin Healthcare

Minneapolis, Minnesota, 55415

United States

HealthPartners Regions Hospital

Saint Paul, Minnesota, 55101

United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Solventum US LLC

Sher-ree Beekman, STUDY_DIRECTOR, Solventum

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-28

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-10-28

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Trauma-related Wound
Surgical Incision
Surgical Wound
Laceration