Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

Study Overview
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Brief Summary
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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: Primary Objectives: Determine if the use of honey as an alternative treatment will reduce site inflammation/irritation and pain associated with pressure ulcers compared to the standard treatment options. Specifically, the investigators will monitor patient PUSH scores, Braden Risk Scale scores, granulation and/or epithelial tissue progression, length of time to heal, patient pain assessments via the Wong Baker Face or Numeric Scale, wound odors, and incidence of adverse events (measured by allergies, stinging sensations, bacterial infections that warrant antibiotic intervention, etc.). Secondary Objective: Patients in the honey treatment group will have lower costs per healed ulcer than patients in the standard collagenase treatment group.

Detailed Description
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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.

Official Title
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Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Other: Leptospermum scoparium honey
* Other: Standard of Care Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (18 years old and older) Newly admitted patients with a diagnosis Pressure Ulcers (Stages III and IV) or patients who develop nosocomial pressure ulcers Stage III and Stage IV Ability to provide written informed consent (either patient or legal personal representative) Exclusion Criteria: Patient/representative refuses to give written informed consent Patient diagnosed with terminal illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Care - Stage III Pressure Ulcers<br>Patients with a stage III pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings). | Other: Standard of Care Treatment<br>* No information available- PI left- study being withdrawn.<br>|
| Experimental: Honey Treatment - Stage III Pressure Ulcers<br>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. | Other: Leptospermum scoparium honey<br>* No information available- PI left- study being withdrawn.<br>|
| Other: Standard Care - Stage IV Pressure Ulcers<br>Patients with a stage IV pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings). | Other: Standard of Care Treatment<br>* No information available- PI left- study being withdrawn.<br>|
| Experimental: Honey Treatment - Stage IV Pressure Ulcers<br>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. | Other: Leptospermum scoparium honey<br>* No information available- PI left- study being withdrawn.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs treated per ulcer |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Care, Medical Grade Honey, Pressure Ulcers