Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

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Estati

Patwone

New York City Health and Hospitals Corporation

ESÈ KLINIK: NCT02689310

BioSeek: NCT02689310

Mo kle

Abstrè

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.

Deskripsyon

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.

Dat

Dènye verifye:	03/31/2018
Premye Soumèt:	02/07/2016
Enskripsyon Estimasyon Soumèt:	02/17/2016
Premye afiche:	02/22/2016
Dènye Mizajou Soumèt:	04/15/2018
Dènye Mizajou afiche:	04/17/2018
Dat aktyèl kòmanse etid la:	02/28/2018
Dat Estimasyon Prensipal Estimasyon an:	03/31/2018
Dat estime fini etid la:	03/31/2018

Kondisyon oswa maladi

Pressure Ulcers

Entèvansyon / tretman

Other: Leptospermum scoparium honey

Other: Standard of Care Treatment

Faz

Faz 4

Gwoup bra

Bra	Entèvansyon / tretman
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).
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: 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).
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.

Kritè kalifikasyon yo

Laj ki kalifye pou etid	18 Years Pou 18 Years
Sèks ki kalifye pou etid	All
Aksepte Volontè Healthy	Wi
Kritè	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

Rezilta

Mezi Rezilta Prensipal yo

1. Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale [6 weeks]

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.

2. Odor (scored as no odor, odor on dressing change, odor all the time) [6 weeks]

Observed by staff and patient, will be scored as no odor, odor on dressing change, odor all the time.

3. Incidence of adverse events [6 weeks]

4. Braden Scale assessment [6 weeks]

5. Irritation [6 weeks]

Presence or absence of irritation as determined by clinical observation

6. Inflammation [6 weeks]

Presence or absence of irritation as determined by clinical observation

7. Pain [6 weeks]

Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)

Mezi Rezilta Segondè

1. Costs treated per ulcer [1 year]

Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

Mo kle

alginate

inflammation

ulcer

hypersensitivity

pressure ulcer

leptospermum

leptospermum scoparium

antibyotik