Comparing SynEx Wound Cleanser to Saline for Traumatic Wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to evaluate the effectiveness of SynEx Wound Cleanser compared to standard saline treatment in patients with traumatic wounds, including gunshot, penetrating, and burn injuries. Participants will attend up to four visits, use the assigned wound cleanser, and complete surveys regarding their healing progress and overall well-being. The study focuses on acute wounds of the upper or lower extremities, assessing the healing outcomes associated with each treatment method.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type:

   1. 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.
   2. 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.
   3. 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.
2. Males and females ≥18 years old.
3. Has access to a computer or mobile device for telepresence visits.
4. Able to give informed consent and willing to comply with all required study procedures.

Exclusion Criteria:

1. Any wound likely to require irrigation and debridement in an operating room (OR) setting.
2. 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.).
3. \> 72 hrs from initial injury.
4. Pregnant or lactating females.
5. Patients with known allergy(ies) to any of the components of the study irrigation system.
6. Patients who are considered by the investigator for any reason to be an unsuitable candidate.

Where it's running

• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Barnes Jewish Hospital
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Shenda Baker, PhD — Synedgen, Inc.
• Study coordinator: Shenda Baker, PhD
• Email: sb@synedgen.com
• Phone: (909) 447-6858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.