Back to Trials
NCT05743283NARecruiting

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

Synedgen, Inc.

Start Date

4/12/2023

Completion Date

9/1/2025

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

SynEx Wound Cleanser

OTHER

Saline

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Wound Heal

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Barnes Jewish Hospital

St Louis, Missouri 63110

United States