Safety Evaluation of Amicidin- Topical Solution Applied During Surgery for Infected Surgical or Traumatic Wounds in Adults

What this Trial Is About

Researchers are evaluating the safety of Amicidin- topical solution when applied directly into infected surgical or traumatic wounds during surgery. This Phase 1 trial aims to determine if Amicidin- is safe enough for larger trials, whether it is absorbed into the bloodstream from local wound application, and how easy it is for surgeons to use. The study compares standard wound care alone with standard care combined with Amicidin- to monitor for any drug-related side effects. Participants will be assigned in three sequential groups, with about 44 patients total. Within each group, participants are randomly assigned to receive either standard care alone or standard care plus Amicidin- topical solution in different doses and application methods, such as 15 mL or 50 mL applied just before wound closure, with or without rinsing with saline. The treatment is applied during surgery to manage infected wounds. During the study, participants will be monitored for up to 30 days to observe any adverse events related to the treatments. Researchers will also measure how much of the drug enters the bloodstream during the first three days. Safety assessments, including clinical evaluations and adverse event tracking, will guide understanding of the treatments effects. Participants will be followed closely through this period to collect all necessary data.

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