Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Synedgen, Inc. · with United States Department of Defense, Medical Technology Enterprise Consortium · NCT05743283
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 100
- US sites recruiting
- 2
- Study start
- April 12, 2023
- Record last updated
- May 16, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: SynEx Wound Cleanser; Saline
Conditions: Wound Heal
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
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.
Recruiting US locations
MedStar Washington Hospital Center
Washington D.C., DC 20010
Site contact: Alison Ross · 202-877-4707 · Alison.R.Ross@medstar.net
Barnes Jewish Hospital
St Louis, MO 63110
Site contact: Jamie Mills, BS, CCRC · 314-273-1382 · jamiem@wustl.edu
Study contacts (from the official record)
- Shenda Baker, PhD · (909) 447-6858 · sb@synedgen.com
- Kaveri Parker, PhD · (909) 447-6858 · kp@synedgen.com