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: 1. 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.). 2. Secondary Objective: Patients in the honey treatment group will have lower costs per healed ulcer than patients in the standard collagenase treatment group.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
No information available- PI left- study being withdrawn.
No information available- PI left- study being withdrawn.
NYC Health + Hospitals/Coney Island
Brooklyn, New York, United States
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.
Time frame: 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.
Time frame: 6 weeks
Incidence of adverse events
Time frame: 6 weeks
Braden Scale assessment
Time frame: 6 weeks
Irritation
Presence or absence of irritation as determined by clinical observation
Time frame: 6 weeks
Inflammation
Presence or absence of irritation as determined by clinical observation
Time frame: 6 weeks
Pain
Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)
Time frame: 6 weeks
Costs treated per ulcer
Time frame: 1 year
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