Experimental device trial launches – details under wraps
NCT ID NCT06217081
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This clinical trial is testing a device that has not been approved or cleared by the U.S. FDA. The purpose is to learn more about how the device works and its effects on participants. Because key details are not publicly available, the exact goals and methods are unclear.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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78 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 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 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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