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New treatment option for Surgical Wound Infection
Official title A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections
ClinicalTrials.gov ID: NCT07379684
What this study is testing
What is Amicidin-β topical solution - 15 mL?
Amicidin-β topical solution - 15 mL is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for surgical wound infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into infected surgical or traumatic wounds during a surgical procedure. The main questions it aims to answer are: 1.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Main
- 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...
- Purulent drainage
- Erythema
You likely can't join if
- 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
See the full eligibility criteria
- Main
- 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...
- 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 treatment 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Torrance, California, United States
- Idaho Falls, Idaho, United States
- Baltimore, Maryland, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torrance, California, United States; Idaho Falls, Idaho, United States; Baltimore, Maryland, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.