Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

Withdrawn before enrolling · Phase 4

Conditions studied: Pressure Ulcers

In brief

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.

Key facts

Study ID

NCT02689310

Run by

New York City Health and Hospitals Corporation

People needed

0

Starts

2018-03-01

Expected to finish

2018-04-01

Last updated by the study team

2018-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• Patient/representative refuses to give written informed consent
• Patient diagnosed with terminal illness

Where it is running

• NYC Health + Hospitals/Coney Island — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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