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RECRUITING
NCT05743283
NA

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

Sponsor: Synedgen, Inc.

View on ClinicalTrials.gov

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

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.

Locations (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Barnes Jewish Hospital

St Louis, Missouri, United States