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

Exclusion Criteria

• •Patients with any of the following will be excluded:
• •Surgical or traumatic wound associated with surrounding cellulitis extending ≥10 cm from the wound edge
• •Necrotizing fasciitis or gangrenous ulcer
• •Multiple surgical or traumatic wound infections at different sites
• •Surgical or traumatic wound infection overlying unhealed bone fracture
• •Surgical or traumatic wound infection with open peritoneal cavity
• •Surgical or traumatic wound infection extending to an organ space
• •Surgical or traumatic wound infection with or adjacent to implanted surgical hardware. 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 lower extremity
• •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 discretion