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Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Sponsor: 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.
Official title: Efficacy of SynEx™ Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-04-12
Completion Date
2025-09
Last Updated
2024-05-16
Healthy Volunteers
No
Conditions
Interventions
SynEx 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.
Saline
The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.
Locations (2)
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Barnes Jewish Hospital
St Louis, Missouri, United States