RecruitingNot ApplicableNCT05743283

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

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


Sponsor

Synedgen, Inc.

Enrollment

100 participants

Start Date

Apr 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wound rinse solution called SynEx for treating traumatic wounds in civilian patients — wounds that mimic the kinds of injuries seen in military combat settings, including lacerations, punctures, gunshot wounds, and partial-thickness burns. Wound infection is a major complication of traumatic injuries, and effective irrigation and cleaning solutions are essential to reduce bacterial contamination and promote healing. SynEx is being evaluated for its safety and effectiveness compared to standard wound care. Eligible participants must be 18 years or older with acute penetrating, puncture, gunshot, or burn wounds of the arms or legs that meet specific severity criteria, and be seen within 72 hours of the injury. Pregnant or lactating women, patients requiring surgical debridement in an operating room, those with serious secondary injuries (like traumatic brain injury or sepsis), or those with known allergies to study components are excluded. This research is significant because wound care is one of the most fundamental yet consequential aspects of trauma management. Inadequate wound cleaning increases the risk of infection, tissue loss, and in severe cases, amputation or death. A superior wound rinse solution could benefit emergency rooms, military field medicine, and disaster response settings — improving outcomes for millions of trauma patients globally, particularly in resource-limited environments where infection control options are limited.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

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

Barnes Jewish Hospital

St Louis, Missouri, United States

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NCT05743283


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