Who is eligible for clinical trial NCT05743283?

Participants must meet protocol criteria for Wound Heal. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05743283 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-05-15

Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds (NCT05743283)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Synedgen, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (7 items).

Location: MedStar Washington Hospital Center — Washington D.C., District of Columbia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type:
Penetrating, puncture or laceration wounds: stage II-III (partial to full thickness loss of dermis) excluding diabetic or venous wounds, and pressure ulcers and perforated wounds (except gunshot wounds) and wounds with exposed bones, facia or muscle.
Gunshot wounds (GSW): Grade I - II on the Red Cross Classification of War Wounds6 (diameter of entry + exit wounds \< 10 cm, wound cavity or not, no fracture or fraction without clinically significant comminution). Non-penetrating, penetrating, or perforated GSW are included. GSW with suspected vascular injuries or nerve damage are excluded.
Burns: partial thickness injury ≤ 9% TBSA. Thermal burn from flame or scald, chemical burns, and electrical burn are included. Radiation and frostbite burns are excluded.
Males and females ≥18 years old.
Has access to a computer or mobile device for telepresence visits.
Able to give informed consent and willing to comply with all required study procedures.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Any wound likely to require irrigation and debridement in an operating room (OR) setting.
Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, traumatic brain injury, other serious or unstabilized organ damage from trauma, etc.).
\> 72 hrs from initial injury.
Pregnant or lactating females.
Patients with known allergy(ies) to any of the components of the study irrigation system.
Patients who are considered by the investigator for any reason to be an unsuitable candidate.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

MedStar Washington Hospital Center — Washington D.C., District of Columbia
Barnes Jewish Hospital — St Louis, Missouri

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗