Recruiting

SynEx Wound Cleanser

Sponsor:

Synedgen, Inc.

Code:

NCT05743283

Conditions

Wound Heal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SynEx Wound Cleanser

Saline

Study Details

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

Study ID

NCT05743283

Start date

Apr 12, 2023

Status verified date

May, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Saline

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

MedStar Washington Hospital Center

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Barnes Jewish Hospital

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Jamie Mills, BS, CCRC

314-273-1382jamiem@wustl.edu

Principal Investigator:

Stephen Liang, MD

More Information

Sponsor

Synedgen, Inc.

Last update posted

May 16, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Synedgen, Inc. on 2024-05-16.