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No patients recruited. Study didn't get off the ground. PI left.
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The investigators hypothesize that the use of leptospermum scoparium honey as a type of dressing and/or debridement agent on stage III or IV pressure ulcers has an increased efficacy and safety compared to the current treatment protocol that includes the use of hydrogel/Vaseline, collagenase, and silver alginate dressings as the standard of care. Utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as a treatment for Stage III and Stage IV pressure ulcers will not be inferior to the comparison treatment of standard of care wound dressings. Moreover, this research design will enable the research team to determine if the honey based dressings are equivalent to or superior to the comparison treatment.
Therefore, the investigators specific study objectives are as follows:
Design: Non-inferiority Trial. This design is intended to demonstrate that Leptospermum scoparium Honey treatment is no worse than the standard treatment for pressure ulcers.
Data Collection Procedures:
Members of the research team will administer all wound care treatments on all of the patients in this research project. After initial evaluation and documentation of the presence of pressure ulcers, patients with Stage III and Stage IV ulcers are randomized into the two groups; treatment and control. Patients that develop nosocomial Stage III and Stage IV pressure ulcers will also be included in this study and randomly placed into one of the groups. The following protocol will be followed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care - Stage III Pressure Ulcers | Other | Patients with a stage III pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings). |
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| Honey Treatment - Stage III Pressure Ulcers | Experimental | Patients with a stage III pressure ulcer who are randomized into this treatment arm will be given leptospermum scoparium honey dressings for treatment of their wound. |
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| Standard Care - Stage IV Pressure Ulcers | Other | Patients with a stage IV pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings). |
|
| Honey Treatment - Stage IV Pressure Ulcers | Experimental | Patients with a stage IV pressure ulcer who are randomized into this treatment arm will be given leptospermum scoparium honey dressings for treatment of their wound. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leptospermum scoparium honey | Other | No information available- PI left- study being withdrawn. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale | Developed by the National Pressure Ulcer Advisory Panel (NPUAP) as a quick and reliable tool to monitor the change in pressure ulcer status over time and has been incorporated as a standard assessment tool in acute care settings. | 6 weeks |
| Odor (scored as no odor, odor on dressing change, odor all the time) | Observed by staff and patient, will be scored as no odor, odor on dressing change, odor all the time. | 6 weeks |
| Incidence of adverse events | 6 weeks | |
| Braden Scale assessment | 6 weeks | |
| Irritation | Presence or absence of irritation as determined by clinical observation | 6 weeks |
| Inflammation | Presence or absence of irritation as determined by clinical observation | 6 weeks |
| Pain | Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Costs treated per ulcer | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYC Health + Hospitals/Coney Island | Brooklyn | New York | 11235 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Standard of Care Treatment | Other | No information available- PI left- study being withdrawn. |
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