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Business decision
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Burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix as the matrix for their wound, in conjunction with the standard of care for managing these types of wounds. The study will be divided into two phases. Phase I will entail intervention with the wound matrix and will continue until one of the following occur, sufficient granulation has occurred and the patient can receive a STSG and proceed to Phase II, the patient's physician determines an STSG is no longer necessary or two applications with the wound matrix occur and no STSG is approved. Phase II will begin following the STSG procedure. In this phase, the wound will be monitored and proportion of STSG take will be evaluated but no application of the wound matrix device will take place. This phase will continue for 28 days or if the physician deems the patient no longer needs regular care to monitor the wound, whichever occurs earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esterified hyaluronic acid matrix | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esterified Hyaluronic Acid Matrix | Device | A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft | Baseline to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wound Volume From the Time Prior to Application of the Wound Device to the Time Before the Application of STSG and After STSG | Baseline to 42 days | |
| Length of Stay in Inpatient Unit | Baseline to 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Esterified Hyaluronic Acid Matrix | Esterified Hyaluronic Acid Matrix: A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study was stopped due to business decision and baseline information, data or subject packets were not collected for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Esterified Hyaluronic Acid Matrix | Esterified Hyaluronic Acid Matrix: A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft | Study was stopped due to business decision and data was not collected for analysis. | Posted | Baseline to 42 days |
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|
Study stopped due to business decision. Baseline, data & Subject packets were not collected.
Study stopped due to business decision. Baseline, data & Subject packets were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esterified Hyaluronic Acid Matrix | Esterified Hyaluronic Acid Matrix: A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss |
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Due to a business decision with the pandemic it was decided to terminate this study and data was never collected from the site or analyzed for this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Miller | Medline Industries | 630-418-6891 | jamiller@medline.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2020 | Nov 2, 2021 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Patient Pain Rating | Baseline to 42 days |
| Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days | 28 days |
| Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture | Baseline to 70 days |
| Subject Discharge Destination | The facility that the subject is discharged to will be captured. | Baseline to 70 days |
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| Age, Continuous |
| Sex: Female, Male |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
| Secondary | Change in Wound Volume From the Time Prior to Application of the Wound Device to the Time Before the Application of STSG and After STSG | Study was stopped due to business decision and data was not collected for analysis. | Posted | Baseline to 42 days |
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| Secondary | Length of Stay in Inpatient Unit | Study was stopped due to business decision and data was not collected for analysis. | Posted | Baseline to 42 days |
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| Secondary | Patient Pain Rating | Study was stopped due to business decision and data was not collected for analysis. | Posted | Baseline to 42 days |
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| Secondary | Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days | Study was stopped due to business decision and data was not collected for analysis. | Posted | 28 days |
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| Secondary | Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture | Study was stopped due to business decision and data was not collected for analysis. | Posted | Baseline to 70 days |
|
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| Secondary | Subject Discharge Destination | The facility that the subject is discharged to will be captured. | Study was stopped due to business decision and data was not collected for analysis. | Posted | Baseline to 70 days |
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