Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

Pressure Ulcers Clinical Trial

Official title:

Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02689310
• Other study ID #: Honey & Wound Care
• Status: Withdrawn
• Phase: Phase 4
• First received: February 8, 2016
• Last updated: April 16, 2018
• Start date: March 1, 2018
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: New York City Health and Hospitals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Other:
• Leptospermum scoparium honey
No information available- PI left- study being withdrawn.
• Standard of Care Treatment
No information available- PI left- study being withdrawn.

Locations

Country	Name	City	State
United States	NYC Health + Hospitals/Coney Island	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York City Health and Hospitals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence of adverse events		6 weeks
Primary	Braden Scale assessment		6 weeks
Primary	Irritation	Presence or absence of irritation as determined by clinical observation	6 weeks
Primary	Inflammation	Presence or absence of irritation as determined by clinical observation	6 weeks
Primary	Pain	Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)	6 weeks
Secondary	Costs treated per ulcer		1 year