Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

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.

Study Overview

• Status: Withdrawn
• Conditions: Pressure Ulcers
• Intervention / Treatment: Other: Standard of Care Treatment; Other: Leptospermum scoparium honey

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11235
      • NYC Health + Hospitals/Coney Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard Care - Stage III Pressure Ulcers; 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; No information available- PI left- study being withdrawn.
Experimental: Honey Treatment - Stage III Pressure Ulcers; 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; No information available- PI left- study being withdrawn.
Other: Standard Care - Stage IV Pressure Ulcers; 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; No information available- PI left- study being withdrawn.
Experimental: Honey Treatment - Stage IV Pressure Ulcers; 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; No information available- PI left- study being withdrawn.

What is the study measuring?

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	Time Frame
Costs treated per ulcer	1 year

Collaborators and Investigators

• Sponsor: New York City Health and Hospitals Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Pressure Ulcers; Wound Care; Medical Grade Honey
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: Honey & Wound Care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No