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

Launched by SYNEDGEN, INC. · Feb 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a new wound cleanser called SynEx Wound Rinse compared to the standard saline solution for treating traumatic wounds, such as gunshot wounds, puncture wounds, and burns. The goal is to see if SynEx can help these wounds heal better. If you are an adult aged 18 or older and have a qualifying wound, you might be eligible to participate. However, certain conditions, like needing surgery for your wound or if you are pregnant, would make you ineligible.

Participants in this study will attend up to four visits where they will use the assigned wound cleanser and complete brief surveys about how their wound is healing and their overall well-being. This will help researchers gather valuable information on how different treatments affect recovery. If you're interested and think you might qualify, it could be a great opportunity to contribute to important medical research while also receiving care for your wound.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type:
• • 1. 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.
• • 2. 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.
• • 3. 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.
• • 2. Males and females ≥18 years old.
• • 3. Has access to a computer or mobile device for telepresence visits.
• • 4. Able to give informed consent and willing to comply with all required study procedures.
• Exclusion Criteria:
• • 1. Any wound likely to require irrigation and debridement in an operating room (OR) setting.
• • 2. 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.).
• • 3. \> 72 hrs from initial injury.
• • 4. Pregnant or lactating females.
• • 5. Patients with known allergy(ies) to any of the components of the study irrigation system.
• • 6. Patients who are considered by the investigator for any reason to be an unsuitable candidate.