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

Sponsor
Synedgen, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05743283
Collaborator
United States Department of Defense (U.S. Fed), Medical Technology Enterprise Consortium (Other)
100
1
2
12
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SynEx Wound Cleanser
  • Other: Saline
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of SynEx™ Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Wound healing environment composite score [Every 7 days]

    The composite score is a summation of wound characterisitcs such size, depth, edges and undermining.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  2. 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.

  3. 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.

  4. 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.

  5. Males and females ≥18 years old.

  6. Has access to a computer or mobile device for telepresence visits.

  7. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barnes Jewish Hospital Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Synedgen, Inc.
  • United States Department of Defense
  • Medical Technology Enterprise Consortium

Investigators

  • Principal Investigator: Shenda Baker, PhD, Synedgen, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Synedgen, Inc.
ClinicalTrials.gov Identifier:
NCT05743283
Other Study ID Numbers:
  • SynEx
First Posted:
Feb 24, 2023
Last Update Posted:
Feb 24, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2023