Actively Recruiting
A Phase 1 Study to Assess Safety and Tolerability of Amicidin-β Topical Solution in Adult Patients Undergoing Interventional Management of Surgical or Traumatic Wound Infection
Led by Macro Biologics, Inc. · Updated on 2026-05-06
44
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Macro Biologics, Inc.
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of Amicidin-β topical solution applied directly into infected surgical or traumatic wounds during surgery. This Phase 1 trial aims to determine if Amicidin-β is safe for larger trials, if it is absorbed into the bloodstream when applied locally, and if surgeons find it easy to use. The study compares standard wound care alone to standard care combined with Amicidin-β to monitor any related side effects. About 44 participants will be divided into three groups receiving different treatments. Each group will be randomized to receive either standard of care (SOC) alone or SOC plus Amicidin-β topical solution in varying doses: 15 mL or 50 mL applied just before wound closure, with or without rinsing with saline. This design allows researchers to assess different dosing approaches and their impact. Participants will be followed for 30 days to record adverse events and check if the drug enters the bloodstream within the first three days after application. Safety outcomes will be carefully monitored, including any treatment-related side effects. The study lasts about one month per participant, with regular assessments to ensure their well-being and collect data on the treatment's safety.
CONDITIONS
Brief Title
A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body Mass Index between 18.5 kg/square meter and 39.9 kg/square meter
- Surgical or traumatic wound infected within 90 days of surgery or trauma with longest dimension between 3 and 15 cm
- Wound infection showing signs such as purulent drainage, erythema, induration, fever, localized heat, pain, or tenderness
- Wound requiring an interventional procedure like incision, drainage, irrigation, or debridement
- Female participants of childbearing potential must use acceptable birth control or abstain during the study (about 30 days)
You will not qualify if you...
- Wound infection with surrounding cellulitis extending 10 cm or more from wound edge
- Confirmed necrotizing fasciitis or gangrenous ulcer
- Multiple wound infections at different sites
- Wound infection overlying bone fracture with non-union
- Wound infection with open peritoneal cavity or extending to an organ space
- Infection involving implanted surgical hardware or prosthesis (excluding drains and packing)
- Wound infection involving head and neck or burn injury
- Suspected or confirmed osteomyelitis or septic arthritis
- Wound infection caused by fungal or mycobacterial organisms
- Neuropathic or diabetic foot ulcer or moderate to severe chronic venous insufficiency in lower extremity wounds
- Wound due to malignancy
- Antibiotic treatment for infections other than the wound infection
- Requirement for supplemental oxygen or mechanical ventilation
- Pulse Oximetry reading of 92% or lower on room air (confirmed by two readings over 15 minutes) unless adjusted for high altitude
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Day 1 to Day 30
Participants receive Standard of Care (SOC) with or without Amicidin-β topical solution applied immediately prior to wound closure or dressing, including rinsing with saline in some groups.
Visits as needed for treatment and monitoring within 30 days
Trial Site Locations
Total: 4 locations
1
Lundquist Institute
Torrance, California, United States, 90502
Actively Recruiting
2
Snake River Research, PLLC
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
3
LifeBridge Health
Baltimore, Maryland, United States, 21215
Actively Recruiting
4
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
D
Daniel J Gowen-Huang, MBA
M
Michael P Bevilacqua, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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