Burn WoundsNCT05877638
SWC for Treatment of Superficial Partial-Thickness Burns
A study testing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel and SILVADENE Cream 1% (silver sulfadiazine) in people with Burn Wounds, run by Synedgen, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Wounds
- What is being tested?
- SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel and SILVADENE Cream 1% (silver sulfadiazine)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Science Center at New Orleans
New Orleans, Louisiana, 70112
About this study
Official title: Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-Thickness Burns
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.
Read the 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).
- Conditions
- Burn Wounds
- Being tested
- SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel, SILVADENE Cream 1% (silver sulfadiazine)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynePure Wound Cleanser and Catasyn Advanced Technology HydrogelDevice
(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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SynePure with Catasyn | Experimental | SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel Receives: Device: SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel |
| Silvadene | Active comparator | Routine care wound rinse and Silvadene cream Receives: Drug: SILVADENE Cream 1% (silver sulfadiazine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healing wound progress across study window
Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area
Measured: Up to 21days
Secondary outcomes (1)
Number of new infection rates
Characterized by local new inflammation, heat, purulence as well as new or increased pain, redness and swelling
Measured: Up to 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start27 Mar 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synedgen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Sponsor
- Investigators
- Shenda Baker, PhD, Principal investigator, Synedgen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877638
- Sponsor's protocol ID
- SWC
- Status last verified
- May 2024
- First submitted
- 27 Mar 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-Thickness Burns
- ClinicalTrials.gov ID
- NCT05877638
- Acronym / sponsor ID
- SWC
- Conditions
- Burn Wounds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Synedgen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SynePure with Catasyn | Experimental | Device: SynePure Wound Cleanser and Catasyn Advanced Technology HydrogelSynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel |
| Silvadene | Active comparator | Drug: SILVADENE Cream 1% (silver sulfadiazine)Routine care wound rinse and Silvadene cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SynePure with Catasyn |
| 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. | Drug | Silvadene |
Primary outcome
Percentage of healing wound progress across study window
Time frame: Up to 21days
Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area
1 secondary outcome
Number of new infection rates
Time frame: Up to 21days
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenda Baker, PhD principal investigator
Synedgen, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel and SILVADENE Cream 1% (silver sulfadiazine) in people with Burn Wounds, run by Synedgen, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of healing wound progress across study window (time frame: Up to 21days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.