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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Synedgen, Inc.
Study ID
NCT05743283
Status
Recruiting
Apply to this trial

Conditions

  • Wound Heal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Apr 12, 2023
Status verified
May 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SynEx
    The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider.
  • Active Comparator: Saline
    The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider.

Primary Outcome Measure

Wound healing environment composite score [ Time Frame: 14 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Alison Ross
[email protected]
202-877-4707
Barnes Jewish HospitalSt LouisMissouri63110
Jamie Mills, BS, CCRC
[email protected]
314-273-1382
Stephen Liang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
MedStar Washington Hospital Center· Washington D.C., DCBarnes Jewish Hospital· St Louis, MO

Related Studies