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SWC for Treatment of Superficial Partial-Thickness Burns

Primary Purpose

Burn Wounds

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
SILVADENE Cream 1% (silver sulfadiazine)
Sponsored by
Synedgen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who have sustained superficial, partial thickness burn wounds no less than 5% and up to 15% of total body surface area (TBSA; 5-15%). Contiguous superficial and deep partial-thickness burns are eligible for inclusion. Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment. Exclusion Criteria: Inability to provide informed consent Deep partial-thickness burns except as noted in the inclusion criteria and full-thickness burns Radiation, chemical or electrical burn injury Patients with burns primarily located to the face, genitals, or span across joints Patients whose burn injury was ≥ 8 days prior to entry into the Burn Center/ Clinic. Patients with uncontrolled cerebrovascular disease, cardiovascular disease, concurrent endocrine, hepatic or renal disease, or other severe conditions for whom, in the investigators' discretion would render study participation unsafe Patients with documented or self-reported shellfish allergies Current pregnancy Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient.

Sites / Locations

  • Louisiana State University Health Science Center at New OrleansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SynePure with Catasyn

Silvadene

Arm Description

SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel

Routine care wound rinse and Silvadene cream

Outcomes

Primary Outcome Measures

Healing wound progress
Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area

Secondary Outcome Measures

New infection rates
Characterized by local new inflammation, heat, purulence as well as new or increased pain, redness and swelling

Full Information

First Posted
March 27, 2023
Last Updated
May 17, 2023
Sponsor
Synedgen, Inc.
Collaborators
Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT05877638
Brief Title
SWC for Treatment of Superficial Partial-Thickness Burns
Official Title
Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-Thickness Burns
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synedgen, Inc.
Collaborators
Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.
Detailed Description
Current management options for burn wounds contain silver (nanoparticulate or ionic), hypochlorite, hydrogen peroxide, sulfa agents, chlorhexidine, iodine or other dilute antiseptics meant to provide some measure of antimicrobial protection. However, all of these materials have some proven limitations in facilitating wound healing and also have notable local and systemic adverse effects. None of the current clinical treatments enhance healing and/or reduce scar formation. The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds. This study is a prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to routine care, Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited from the Burn Center/Clinic adult patient pool who have sustained superficial partial-thickness burn wounds that comprise ≤15% of total body surface area (TBSA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SynePure with Catasyn
Arm Type
Experimental
Arm Description
SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
Arm Title
Silvadene
Arm Type
Active Comparator
Arm Description
Routine care wound rinse and Silvadene cream
Intervention Type
Device
Intervention Name(s)
SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
Intervention Description
(FDA) 510(k) cleared wound care medical devices formulated with a novel biocompatible chitosan derivative, poly (acetyl, arginyl) glucosamine. SynePure is optimized for the cleansing and debridement of wounds and thermal injuries, and Catasyn serves as a protective gel dressing.
Intervention Type
Drug
Intervention Name(s)
SILVADENE Cream 1% (silver sulfadiazine)
Intervention Description
SILVADENE Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.
Primary Outcome Measure Information:
Title
Healing wound progress
Description
Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area
Time Frame
Up to 21days
Secondary Outcome Measure Information:
Title
New infection rates
Description
Characterized by local new inflammation, heat, purulence as well as new or increased pain, redness and swelling
Time Frame
Up to 21days
Other Pre-specified Outcome Measures:
Title
Complications other than infection
Description
Complications such as gangrene, necrosis, periwound dermatitis and/or edema, hematoma, or any other complication determined to be related to the wound and/or treatment
Time Frame
Up to 21days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have sustained superficial, partial thickness burn wounds no less than 5% and up to 15% of total body surface area (TBSA; 5-15%). Contiguous superficial and deep partial-thickness burns are eligible for inclusion. Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment. Exclusion Criteria: Inability to provide informed consent Deep partial-thickness burns except as noted in the inclusion criteria and full-thickness burns Radiation, chemical or electrical burn injury Patients with burns primarily located to the face, genitals, or span across joints Patients whose burn injury was ≥ 8 days prior to entry into the Burn Center/ Clinic. Patients with uncontrolled cerebrovascular disease, cardiovascular disease, concurrent endocrine, hepatic or renal disease, or other severe conditions for whom, in the investigators' discretion would render study participation unsafe Patients with documented or self-reported shellfish allergies Current pregnancy Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient.
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
Louisiana State University Health Science Center at New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shana Lennard, RN, CCRP
Phone
504-702-5171
Email
slenna@lsuhsc.edu

12. IPD Sharing Statement

Learn more about this trial

SWC for Treatment of Superficial Partial-Thickness Burns

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