A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections

Conditions

• Surgical Wound Infection
• Traumatic Wound Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• Amicidin-β topical solution - 15 mL — DRUG
  Amicidin-β topical solution for local administration - 15 mL
• Amicidin-β topical solution - 50 mL — DRUG
  Amicidin-β topical solution for local administration - 50 mL
• Standard of Care (SOC) — DRUG
  Per institutional Standard Of Care

Study Details

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.

Key Dates

Start date

May 31, 2026

Status verified

Jan 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

44 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: SOC + Amicidin-β topical solution - 15 mL
  In addition to Standard of Care (SOC), patients will receive Amicidin-β topical solution - 15 mL immediately prior to wound closure/dressing, with rinsing out with saline.
• Experimental: SOC + Amicidin-β topical solution - 50 mL - Scheme 1
  In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, with rinsing out with saline
• Experimental: SOC + Amicidin-β topical solution - 50 mL - Scheme 2
  In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, without rinsing out with saline
• Active Comparator: SOC
  Patients will receive Standard of Care (SOC) only

Primary Outcome Measure

Overall 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 ]

Central Contacts

• Daniel J Gowen-Huang, MBA
  (323) 717-0302
  [email protected]
• Michael P Bevilacqua, MD, PhD
  (303) 881-5169
  [email protected]

Locations (4)

Find similar trials in Torrance, CA

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