Clinical Trial: Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
Brief Summary:
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 Summary:
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.
Sponsor: New York City Health and Hospitals Corporation
Current Primary Outcome:
- Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale [ Time Frame: 6 weeks ]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.
- Odor (scored as no odor, odor on dressing change, odor all the time) [ Time Frame: 6 weeks ]Observed by staff and patient, will be scored as no odor, odor on dressing change, odor all the time.
- Incidence of adverse events [ Time Frame: 6 weeks ]
- Braden Scale assessment [ Time Frame: 6 weeks ]
- Irritation [ Time Frame: 6 weeks ]Presence or absence of irritation as determined by clinical observation
- Inflammation [ Time Frame: 6 weeks ]Presence or absence of irritation as determined by clinical observation
- Pain [ Time Frame: 6 weeks ]Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)
Original Primary Outcome: Same as current
Current Secondary Outcome: Costs treated per ulcer [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: New York City Health and Hospitals Corporation
Dates:
Date Received: February 8, 2016
Date Started: March 2016
Date Completion: June 2017
Last Updated: March 21, 2016
Last Verified: March 2016
