NCT05743283

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Synedgen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-12
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-02-24
• Last updated: 2024-05-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study