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Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

Primary Purpose

Pressure Ulcers

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Leptospermum scoparium honey
Standard of Care Treatment
Sponsored by
New York City Health and Hospitals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcers focused on measuring Wound Care, Medical Grade Honey, Pressure Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NYC Health + Hospitals/Coney Island

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Other

Experimental

Arm Label

Standard Care - Stage III Pressure Ulcers

Honey Treatment - Stage III Pressure Ulcers

Standard Care - Stage IV Pressure Ulcers

Honey Treatment - Stage IV Pressure Ulcers

Arm Description

Patients with a stage III pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings).

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.

Patients with a stage IV pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings).

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.

Outcomes

Primary Outcome Measures

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.
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.
Incidence of adverse events
Braden Scale assessment
Irritation
Presence or absence of irritation as determined by clinical observation
Inflammation
Presence or absence of irritation as determined by clinical observation
Pain
Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)

Secondary Outcome Measures

Costs treated per ulcer

Full Information

First Posted
February 8, 2016
Last Updated
April 16, 2018
Sponsor
New York City Health and Hospitals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02689310
Brief Title
Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
Official Title
Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No patients recruited. Study didn't get off the ground. PI left.
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York City Health and Hospitals Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
Wound Care, Medical Grade Honey, Pressure Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care - Stage III Pressure Ulcers
Arm Type
Other
Arm Description
Patients with a stage III pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings).
Arm Title
Honey Treatment - Stage III Pressure Ulcers
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care - Stage IV Pressure Ulcers
Arm Type
Other
Arm Description
Patients with a stage IV pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings).
Arm Title
Honey Treatment - Stage IV Pressure Ulcers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Leptospermum scoparium honey
Intervention Description
No information available- PI left- study being withdrawn.
Intervention Type
Other
Intervention Name(s)
Standard of Care Treatment
Intervention Description
No information available- PI left- study being withdrawn.
Primary Outcome Measure Information:
Title
Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale
Description
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
Title
Odor (scored as no odor, odor on dressing change, odor all the time)
Description
Observed by staff and patient, will be scored as no odor, odor on dressing change, odor all the time.
Time Frame
6 weeks
Title
Incidence of adverse events
Time Frame
6 weeks
Title
Braden Scale assessment
Time Frame
6 weeks
Title
Irritation
Description
Presence or absence of irritation as determined by clinical observation
Time Frame
6 weeks
Title
Inflammation
Description
Presence or absence of irritation as determined by clinical observation
Time Frame
6 weeks
Title
Pain
Description
Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Costs treated per ulcer
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
NYC Health + Hospitals/Coney Island
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

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