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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743283
• Other study ID #: SynEx
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Synedgen, Inc.
• Contact: Shenda Baker, PhD
• Phone: (909) 447-6858
• Email: sb[@]synedgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Device:
• SynEx Wound Cleanser
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.

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

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Synedgen, Inc.	Medical Technology Enterprise Consortium, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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