Actively Recruiting
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
Eligibility Criteria
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
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
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
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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