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

Synedgen

Status: Enrolling

Conditions: Wound Heal

Treatments: Other: Saline; Device: SynEx Wound Cleanser

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency; Other

Identifiers

NCT05743283

SynEx

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

SynEx

Experimental group

Description:

The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider.

Treatment:

Device: SynEx Wound Cleanser

Saline

Active Comparator group

Description:

The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider.

Treatment:

Other: Saline