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

Primary Purpose

Wound Heal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SynEx Wound Cleanser
Saline
Sponsored by
Synedgen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type: 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. 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. 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. Males and females ≥18 years old. Has access to a computer or mobile device for telepresence visits. Able to give informed consent and willing to comply with all required study procedures. Exclusion Criteria: Any wound likely to require irrigation and debridement in an operating room (OR) setting. 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.). > 72 hrs from initial injury. Pregnant or lactating females. Patients with known allergy(ies) to any of the components of the study irrigation system. Patients who are considered by the investigator for any reason to be an unsuitable candidate.

Sites / Locations

  • MedStar Washington Hospital Center
  • Barnes Jewish HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SynEx

Saline

Arm Description

The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider.

The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
May 17, 2023
Sponsor
Synedgen, Inc.
Collaborators
United States Department of Defense, Medical Technology Enterprise Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT05743283
Brief Title
Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Official Title
Efficacy of SynEx™ Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synedgen, Inc.
Collaborators
United States Department of Defense, Medical Technology Enterprise Consortium

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SynEx
Arm Type
Experimental
Arm Description
The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider.
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider.
Intervention Type
Device
Intervention Name(s)
SynEx Wound Cleanser
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.
Primary Outcome Measure Information:
Title
Wound healing environment composite score
Description
The composite score is a summation of wound characterisitcs such size, depth, edges and undermining.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type: 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. 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. 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. Males and females ≥18 years old. Has access to a computer or mobile device for telepresence visits. Able to give informed consent and willing to comply with all required study procedures. Exclusion Criteria: Any wound likely to require irrigation and debridement in an operating room (OR) setting. 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.). > 72 hrs from initial injury. Pregnant or lactating females. Patients with known allergy(ies) to any of the components of the study irrigation system. Patients who are considered by the investigator for any reason to be an unsuitable candidate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shenda Baker, PhD
Phone
(909) 447-6858
Email
sb@synedgen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kaveri Parker, PhD
Phone
(909) 447-6858
Email
kp@synedgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shenda Baker, PhD
Organizational Affiliation
Synedgen, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Mills, BS, CCRC
Phone
314-273-1382
Email
jamiem@wustl.edu
First Name & Middle Initial & Last Name & Degree
Stephen Liang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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