Clinical trial NCT05743283: Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Official title: Efficacy of SynEx™ Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound Heal
Lead sponsor: Synedgen, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
name: Medical Technology Enterprise Consortium
First posted: 2023-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Wound healing environment composite score
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Synedgen, Inc.
name: Shenda Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References: