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. Is Amicidin-β topical solution safe to test in larger clinical trials? 2. Is Amicidin-β topical solution absorbed into the bloodstream from local wound application? 3. Is Amicidin-β topical solution easy for the surgeon to use? Participants will receive either standard of care alone, or standard of care with intrawound Amicidin-β topical solution for the management of their wound infection. Researchers will compare these two groups (standard of care alone to standard of care with Amicidin-β topical solution) to see if there are any study drug-related adverse effects.
This is a Standard of Care (SOC)- controlled study of approximately 44 patients divided into three sequential cohorts of 8, 12, and 24 patients. Within each sequential cohort, patients will be randomized to SOC only or to SOC plus Amicidin-β topical solution in a 1:3 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Amicidin-β topical solution for local administration - 15 mL
Amicidin-β topical solution for local administration - 50 mL
Per institutional Standard Of Care
Lundquist Institute
Torrance, California, United States
RECRUITINGSnake River Research, PLLC
Idaho Falls, Idaho, United States
RECRUITINGLifeBridge Health
Baltimore, Maryland, United States
RECRUITINGWashington University in St. Louis
St Louis, Missouri, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
RECRUITINGOverall comparison of treatment emergent adverse events (TEAES) of combined SOC + Amicidin-β topical solution recipients to SOC only recipients across 3 cohorts.
Time frame: From Day 1 to Day 30
Number of participants with Treatment Emergent Adverse Events (TEAEs) by severity according to the study protocol.
Time frame: From Day 1 to Day 30
Measurement of systemic absorption of Amicidin-β recipients.
Systemic absorption will be assessed by single molecule array (Simoa) immunoassay measurements of patient plasma.
Time frame: From Day 1 to Day 3
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