Clinical trial NCT02689310: Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
Official title: Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pressure Ulcers
Keywords: Wound Care
Medical Grade Honey
Pressure Ulcers
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale
timeFrame: 6 weeks
measure: Odor (scored as no odor, odor on dressing change, odor all the time)
timeFrame: 6 weeks
measure: Incidence of adverse events
timeFrame: 6 weeks
measure: Braden Scale assessment
timeFrame: 6 weeks
measure: Irritation
timeFrame: 6 weeks
measure: Inflammation
timeFrame: 6 weeks
measure: Pain
timeFrame: 6 weeks
Secondary outcomes:
measure: Costs treated per ulcer
timeFrame: 1 year
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYC Health + Hospitals/Coney Island
state: New York
Study officials:
References: