Comparing SynEx Wound Cleanser to Saline for Traumatic Wounds

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

This study is testing whether a new wound cleanser called SynEx works better than regular saline for helping people heal from traumatic wounds like gunshot or burn injuries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Synedgen, Inc. (industry)
• Drugs / interventions: Radiation
• Locations: 2 sites (Washington D.C., District of Columbia and 1 other locations)
• Trial ID: NCT05743283 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute penetrating, puncture, or burn wounds of the upper or lower extremities.

Not a fit: Patients with diabetic or venous wounds, pressure ulcers, or those with significant vascular or nerve damage are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved wound healing outcomes for patients with traumatic injuries.

How similar studies have performed: While similar approaches have been explored, the specific use of SynEx Wound Cleanser in this context is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Washington D.C., District of Columbia and 1 other locations

• 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

Conditions: Wound Heal