Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Patient/representative refuses to give written informed consent
- •Patient diagnosed with terminal illness
研究组 & 干预措施
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).
干预措施: Standard of Care Treatment (Other)
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.
干预措施: Leptospermum scoparium honey (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).
干预措施: Standard of Care Treatment (Other)
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.
干预措施: Leptospermum scoparium honey (Other)
结局指标
主要结局
Incidence of adverse events
时间窗: 6 weeks
Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale
时间窗: 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.
Odor (scored as no odor, odor on dressing change, odor all the time)
时间窗: 6 weeks
Observed by staff and patient, will be scored as no odor, odor on dressing change, odor all the time.
Braden Scale assessment
时间窗: 6 weeks
Irritation
时间窗: 6 weeks
Presence or absence of irritation as determined by clinical observation
Inflammation
时间窗: 6 weeks
Presence or absence of irritation as determined by clinical observation
Pain
时间窗: 6 weeks
Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)
次要结局
- Costs treated per ulcer(1 year)