SWC for Treatment of Superficial Partial-Thickness Burns
NCT ID: NCT05877638
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2023-03-27
2024-06-20
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SynePure with Catasyn
SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
(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.
Silvadene
Routine care wound rinse and Silvadene cream
SILVADENE Cream 1% (silver sulfadiazine)
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.
Interventions
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SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
(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.
SILVADENE Cream 1% (silver sulfadiazine)
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.
Eligibility Criteria
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Inclusion Criteria
* Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment.
* 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.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Louisiana State University Health Sciences Center in New Orleans
OTHER
Synedgen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shenda Baker, PhD
Role: PRINCIPAL_INVESTIGATOR
Synedgen, Inc.
Locations
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Louisiana State University Health Science Center at New Orleans
New Orleans, Louisiana, United States
Countries
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Other Identifiers
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SWC
Identifier Type: -
Identifier Source: org_study_id