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

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 12, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Wound Heal
Interventions
DEVICE

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.

OTHER

Saline

The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.

Trial Locations (2)

20010

RECRUITING

MedStar Washington Hospital Center, Washington D.C.

63110

RECRUITING

Barnes Jewish Hospital, St Louis

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Medical Technology Enterprise Consortium

UNKNOWN

lead

Synedgen, Inc.

INDUSTRY