Efficacy of SynEx™ Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Synedgen, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceSynEx Wound Cleanser
SynEx is a concentrated form of SynePure®, an FDA 510(k) cleared aqueous, osmotically balanced wound cleanser containing patented chitosan derivatives. The ingredients are USP purified water, chitosan arginine (a patented chitosan derivative), sorbitol powder, and betaine. SynEx cleanser is packaged in a collapsible plastic pouch for reconstitution in water before debriding and cleansing a wound.
- OtherSaline
The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.
Locations (2)
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- Barnes Jewish HospitalSt Louis, Missouri