Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SynEx
The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider.
  • 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.
Active Comparator
Saline
The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider.
  • Other: Saline
    The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Alison Ross
202-877-4707
Alison.R.Ross@medstar.net

More Details

Status
Recruiting
Sponsor
Synedgen, Inc.

Study Contact

Shenda Baker, PhD
(909) 447-6858
sb@synedgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.