Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

NCT02689310 | Withdrawn Phase 4

• 1 other identifier: Honey & Wound Care
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 2.Secondary Objective: Patients in the honey treatment group will have lower costs per healed ulcer than patients in the standard collagenase treatment group.

Conditions

Pressure Ulcers

Keywords

Wound Care; Medical Grade Honey; Pressure Ulcers

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Costs treated per ulcer

  1 year

Study Arms (4)

Standard Care - Stage III Pressure Ulcers

OTHER

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

Honey Treatment - Stage III Pressure Ulcers

EXPERIMENTAL

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

Standard Care - Stage IV Pressure Ulcers

OTHER

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

Honey Treatment - Stage IV Pressure Ulcers

EXPERIMENTAL

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

Interventions

Leptospermum scoparium honey OTHER

No information available- PI left- study being withdrawn.

Honey Treatment - Stage III Pressure Ulcers; Honey Treatment - Stage IV Pressure Ulcers

Standard of Care Treatment OTHER

No information available- PI left- study being withdrawn.

Standard Care - Stage III Pressure Ulcers; Standard Care - Stage IV Pressure Ulcers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

NYC Health + Hospitals/Coney Island

Brooklyn, New York, 11235, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 23, 2016
• Study Start: March 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

US (1)