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Tissue Adhesive
3M Topical Tissue Adhesive for Cuts (Lublin Trial)
N/A
Recruiting
Research Sponsored by Solventum US LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is at least 22 years of age on the date of informed consent
Be older than 18 years old
Must not have
Subject has a laceration or incision that is > 100 mm (10 cm) in length
Subject has a wound with any of the following etiologies: human or animal bite, prolonged pressure (ie, decubitus)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of 3M™ Topical Tissue Adhesive on people with cuts or surgical wounds. Participants will be randomly assigned to receive either 3M™
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include skin irritation, allergic reactions at the application site, infection risk due to improper wound closure, or differences in how well each adhesive holds the wound edges together.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a cut or surgical cut longer than 10 cm.
Select...
My wound is from a bite or has been caused by prolonged pressure.
Select...
I have a wound in a sensitive area, like near my eyes, mouth, over a joint, or where there's a lot of hair.
Select...
I do not have severe vascular disease, uncontrolled diabetes, clotting disorders, immune issues, or major infections.
Select...
I have surgical cuts that are close to each other.
Select...
My wound is severe, possibly showing exposed bone or needs special closure methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Apposition of skin edges
Tissue adhesive remaining
Other study objectives
Vancouver Scar Scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational Topical Tissue AdhesiveExperimental Treatment1 Intervention
3M Topical Tissue Adhesive
Group II: Control Topical Tissue AdhesiveActive Control1 Intervention
Histoacryl® Blue Topical Skin Adhesive
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
917 Previous Clinical Trials
334,247 Total Patients Enrolled
1 Trials studying Surgical Wound
The University of Texas Health Science Center at San AntonioOTHER
477 Previous Clinical Trials
92,518 Total Patients Enrolled
1 Trials studying Surgical Wound
56 Patients Enrolled for Surgical Wound
Solventum US LLCLead Sponsor
65 Previous Clinical Trials
9,998 Total Patients Enrolled
3 Trials studying Surgical Wound
363 Patients Enrolled for Surgical Wound
3MIndustry Sponsor
159 Previous Clinical Trials
31,124 Total Patients Enrolled
11 Trials studying Surgical Wound
4,397 Patients Enrolled for Surgical Wound
Sher-ree BeekmanStudy DirectorSolventum
1 Previous Clinical Trials
90 Total Patients Enrolled