Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds

Exclusion Criteria12

• Penetrating, puncture or laceration wounds: stage II-III (partial to full thickness loss of dermis) excluding diabetic or venous wounds, and pressure ulcers and perforated wounds (except gunshot wounds) and wounds with exposed bones, facia or muscle.
• Gunshot wounds (GSW): Grade I - II on the Red Cross Classification of War Wounds6 (diameter of entry + exit wounds < 10 cm, wound cavity or not, no fracture or fraction without clinically significant comminution). Non-penetrating, penetrating, or perforated GSW are included. GSW with suspected vascular injuries or nerve damage are excluded.
• Burns: partial thickness injury ≤ 9% TBSA. Thermal burn from flame or scald, chemical burns, and electrical burn are included. Radiation and frostbite burns are excluded.
• Males and females ≥18 years old.
• Has access to a computer or mobile device for telepresence visits.
• Able to give informed consent and willing to comply with all required study procedures.
• Any wound likely to require irrigation and debridement in an operating room (OR) setting.
• Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, traumatic brain injury, other serious or unstabilized organ damage from trauma, etc.).
• > 72 hrs from initial injury.
• Pregnant or lactating females.
• Patients with known allergy(ies) to any of the components of the study irrigation system.
• Patients who are considered by the investigator for any reason to be an unsuitable candidate.