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

Recruiting now · Not applicable

Conditions studied: Wound Heal

In brief

The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating or burn wounds who participate will be asked to attend up to four study visits, use the assigned wound cleanser and complete brief surveys about their healing and well-being related to the wound healing.

Key facts

Study ID

NCT05743283

Run by

Synedgen, Inc.

People needed

100

Starts

2023-04-12

Expected to finish

2025-09-01

Last updated by the study team

2024-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type:
• 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.

You may not qualify if…

• 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.

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Barnes Jewish Hospital — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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