Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05743283

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

Led by Synedgen, Inc. · Updated on 2024-05-16

100

Participants Needed

2

Research Sites

124 weeks

Total Duration

On this page

Sponsors

S

Synedgen, Inc.

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute penetrating, puncture, or burn wounds on upper or lower limbs meeting wound type criteria
  • Penetrating, puncture, or laceration wounds: stage II-III (partial to full thickness dermis loss), excluding diabetic, venous wounds, pressure ulcers, and perforated wounds except gunshot wounds
  • Gunshot wounds classified as Grade I - II by Red Cross (entry + exit wounds < 10 cm, no fracture or non-significant fracture, excluding suspected vascular or nerve damage)
  • Burns: partial thickness injury ≤ 9% total body surface area, including thermal, chemical, and electrical burns; excluding radiation and frostbite burns
  • Males and females aged 18 years or older
  • Access to a computer or mobile device for telepresence visits
  • Ability to give informed consent and willingness to follow all study procedures
Not Eligible

You will not qualify if you...

  • Wounds likely requiring irrigation and debridement in an operating room
  • Concurrent severe injuries or conditions such as inhalational injury needing ventilation, cardiac injury, sepsis, traumatic brain injury, or other serious organ damage
  • More than 72 hours since initial injury
  • Pregnant or lactating females
  • Known allergies to any components of the study irrigation system
  • Investigator-determined unsuitability for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

2

Barnes Jewish Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

S

Shenda Baker, PhD

CONTACT

K

Kaveri Parker, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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