New gel for infected wounds enters first human test
NCT ID NCT07379684
First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 5 times
Summary
This early-stage trial tests a new gel called Amicidin-β, applied directly into infected surgical or traumatic wounds during a procedure. The main goal is to see if it is safe and easy for surgeons to use. About 44 adults will take part, comparing standard care alone to standard care plus the gel.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Amicidin-β topical solution
- What this could lead to
- If safe, this could lead to a new treatment option for wound infections that is applied directly during surgery.
- What could go wrong
- This is a very early Phase 1 trial with only 44 people, so safety and effectiveness are not yet proven. It may not work in larger studies.
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.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- 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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18 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Main Inclusion Criteria: * Body Mass Index between 18.5 kg/square meter and 39.9kg/square meter * Surgical or traumatic wound determined by the Investigator to be infected within 90 days of surgery or trauma, with longest dimension between 3 and 15 cm. The diagnosis should include one or more of the following signs or symptoms: * Purulent drainage * Erythema * Surrounding induration * Fever or localized heat surrounding the wound * Reported localized pain or localized tenderness on examination * Infected surgical or traumatic wound that is determined by the Investigator to required an interventional procedure, such as incision, drainage, irrigation, and/or debridement. * If female of childbearing potential, must have been practicing an acceptable method of birth control as judged by the Investigator for at least one month prior to enrollment. * Females of childbearing potential must agree that for the entire duration of the study (about 30 days), they will either practice true abstinence consistent with their preferred and usual lifestyle, or use double contraceptive methods. Main Exclusion Criteria: Patients with any of the following will be excluded: * Surgical or traumatic wound associated with surrounding cellulitis extending ≥10 cm from the wound edge * Confirmed necrotizing fasciitis or gangrenous ulcer * Multiple surgical or traumatic wound infections at different sites * Surgical or traumatic wound infection overlying bone fracture, with radiological evidence of non-union * Surgical or traumatic wound infection with open peritoneal cavity * Surgical or traumatic wound infection extending to an organ space * Surgical or traumatic wound infection extending to implanted surgical hardware or protesis. Note: surgical drains and packing are permitted * Surgical or traumatic wound infection involving head and neck * Surgical or traumatic wound infection involving burn injury * Suspected or confirmed osteomyelitis or septic arthritis * Surgical or traumatic wound infection known or suspected to be caused by fungal or mycobacterial organisms * Wound with diagnosis of neuropathic or diabetic foot ulcer or a previous diagnosis of moderate to severe chronic venous insufficiency of a lower extremity in patients with an infected surgical to traumatic wound of the lower extremity * Wound due to malignancy * Antibiotic therapy for an infection other than the surgical or traumatic wound infection * Patient requires supplemental O2 or mechanical ventilation * Pulse Oximetry (SpO2) reading of ≤ 92% on room air (confirmed by two additional readings ≤92% over 15 min). At geographic locations of high altitude, a lower SpO2 limit (e.g., ≤ 91%) may be used at Investigator's discretion
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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LifeBridge Health
RECRUITINGBaltimore, Maryland, 21215, United States
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Lundquist Institute
RECRUITINGTorrance, California, 90502, United States
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Snake River Research, PLLC
RECRUITINGIdaho Falls, Idaho, 83404, United States
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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Washington University in St. Louis
RECRUITINGSt Louis, Missouri, 631110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Infection-Fighting stitches tested for C-Sections, but trial stopped early
- Fasting before hip surgery may cut infection risk, new trial hopes to prove
- Vacuum dressing could cut infections after skin graft surgery
- Could a dab of antibiotic gel replace pills after wisdom tooth removal?