Trauma-related WoundLublinNCT06217081

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

A study testing 3M Topical Tissue Adhesive and Histoacryl® Blue Topical Skin Adhesive in people with Trauma-related Wound and Surgical Incision, run by Solventum US LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Trauma-related Wound, Surgical Incision, Surgical Wound
What is being tested?: 3M Topical Tissue Adhesive and Histoacryl® Blue Topical Skin Adhesive
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: No sites listed yet
Study dates: 28 Oct 2024to 24 Jun 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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)

About this study

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

Read the detailed description

This is a multicenter, prospective, open-label, randomized, non-inferiority study that will include 452 randomized Subjects requiring closure of superficial lacerations, clean traumatic lacerations, low-tension incisions, or surgical incisions from minimally invasive surgeries. The study will enroll Subjects from up to 10 sites in the USA.

Subjects will be seen during Screening (no more than 10 days before application of tissue adhesive), on the day in which skin edges of wound(s) are reapproximated and tissue adhesive is applied (Day 0), 10 days after application of the tissue adhesive, and 30 days after application of the tissue adhesive.

Conditions: Trauma-related Wound, Surgical Incision, Surgical Wound, Laceration
Being tested: 3M Topical Tissue Adhesive, Histoacryl® Blue Topical Skin Adhesive
Medical subject headings: Surgical Wound, Lacerations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3M Topical Tissue AdhesiveDevice
Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
Histoacryl® Blue Topical Skin AdhesiveDevice
Application of control topical tissue adhesive to trauma laceration or surgical incision.

Study groups in NCT06217081
Study group	Role	What they receive
Investigational Topical Tissue Adhesive	Experimental	3M Topical Tissue Adhesive Receives: Device: 3M Topical Tissue Adhesive
Control Topical Tissue Adhesive	Active comparator	Histoacryl® Blue Topical Skin Adhesive Receives: Device: Histoacryl® Blue Topical Skin Adhesive

What is being measured

The primary outcome is the main question the study is designed to answer.

Apposition of Skin Edges
Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive
Measured: 10 days

Secondary outcomes (2)

Tissue Adhesive Remaining
Percentage (%) of the sum of the subject's wound length(s), in relation to the sum of the original incision/laceration length(s), with tissue adhesive remaining at 10 days after application of tissue adhesive
Measured: 10 days
Apposition of Skin Edges
Percentage of subjects with wounds with 100% apposition of skin edges at 30 days after application of tissue adhesive
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202424 Jun 2025

First posted22 Jan 2024
Study start28 Oct 2024
Primary completion24 Jun 2025
Study completion24 Jun 2025

Why it stopped: The business has decided to no longer support further development of this product. This decision was informed by a range of factors including the preliminary safety signals observed in the routine interim safety review and strategic reassessment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Trauma-related WoundStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06217081
Sponsor's protocol ID: EM-05-015029
Other IDs: 59MDW-23000524-A
Acronym: Lublin
Status last verified: Jun 2026
First submitted: 30 Dec 2023
Last updated: 27 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06217081
Acronym / sponsor ID: Lublin / EM-05-015029
Conditions: Trauma-related Wound, Surgical Incision, Surgical Wound, Laceration
Study type: Interventional
Recruitment status: TerminatedReason stopped: The business has decided to no longer support further development of this product. This decision was informed by a range of factors including the preliminary safety signals observed in the routine interim safety review and strategic reassessment
Enrolment: 78 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: United States Department of Defense, The University of Texas Health Science Center at San Antonio, 3M
Study start: 28 Oct 2024 (actual)
Primary completion: 24 Jun 2025 (actual)
Study completion: 24 Jun 2025 (actual)
First posted: 22 Jan 2024 (actual)
Results: Posted 27 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Investigational Topical Tissue Adhesive	Experimental	Device: 3M Topical Tissue Adhesive3M Topical Tissue Adhesive
Control Topical Tissue Adhesive	Active comparator	Device: Histoacryl® Blue Topical Skin AdhesiveHistoacryl® Blue Topical Skin Adhesive

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:

Key exclusion criteria (29 listed)

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:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3M Topical Tissue AdhesiveApplication of investigational topical tissue adhesive to trauma laceration or surgical incision.	Device	Investigational Topical Tissue Adhesive
Histoacryl® Blue Topical Skin AdhesiveApplication of control topical tissue adhesive to trauma laceration or surgical incision.	Device	Control Topical Tissue Adhesive

Primary outcome

Apposition of Skin Edges
Time frame: 10 days
Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive

2 secondary outcomes

Tissue Adhesive Remaining
Time frame: 10 days
Apposition of Skin Edges
Time frame: 30 days

Results and safety

Results posted to the registry on 27 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Topical Tissue Adhesive	31	28
Control Topical Tissue Adhesive	27	23

Primary outcome: Apposition of Skin Edges

Time frame: 10 days. Number. Unit: participants

Measure	Reason Outcome Not Evaluated n = 0
Value	0

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomization through end of study participation (Day 30 follow-up visit, ±5 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Topical Tissue Adhesive	4 of 29 (13.8%)	17 of 29 (58.6%)	0 of 29
Control Topical Tissue Adhesive	0 of 26 (0%)	5 of 26 (19.2%)	0 of 26

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing 3M Topical Tissue Adhesive and Histoacryl® Blue Topical Skin Adhesive in people with Trauma-related Wound and Surgical Incision, run by Solventum US LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apposition of Skin Edges (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06217081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.