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

NCT05743283 | Recruiting FDA Device

• 1 other identifier: SynEx
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• Wound healing environment composite score

  The composite score is a summation of wound characteristics such size, depth, edges and undermining. Scores range from range of 13 to 60, representing wound regeneration to degeneration respectively).

  14 days

Study Arms (2)

SynEx

EXPERIMENTAL

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

Device: SynEx Wound Cleanser

Saline

ACTIVE COMPARATOR

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

Other: Saline

Interventions

SynEx Wound Cleanser DEVICE

SynEx is a concentrated form of SynePure®, an FDA 510(k) cleared aqueous, osmotically balanced wound cleanser containing patented chitosan derivatives. The ingredients are USP purified water, chitosan arginine (a patented chitosan derivative), sorbitol powder, and betaine. SynEx cleanser is packaged in a collapsible plastic pouch for reconstitution in water before debriding and cleansing a wound.

SynEx

Saline OTHER

The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Synedgen, Inc.: lead
• United States Department of Defense: collaborator
• Medical Technology Enterprise Consortium: collaborator

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Shenda Baker, PhD

  Synedgen, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenda Baker, PhD

CONTACT

(909) 447-6858; sb@synedgen.com

Kaveri Parker, PhD

CONTACT

(909) 447-6858; kp@synedgen.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: April 12, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)