Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
Palavras-chave
Resumo
Descrição
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.
datas
Última verificação: | 03/31/2018 |
Enviado pela primeira vez: | 02/07/2016 |
Inscrição estimada enviada: | 02/17/2016 |
Postado pela primeira vez: | 02/22/2016 |
Última atualização enviada: | 04/15/2018 |
Última atualização postada: | 04/17/2018 |
Data real de início do estudo: | 02/28/2018 |
Data Estimada de Conclusão Primária: | 03/31/2018 |
Data Estimada de Conclusão do Estudo: | 03/31/2018 |
Condição ou doença
Intervenção / tratamento
Other: Leptospermum scoparium honey
Other: Standard of Care Treatment
Fase
Grupos de Armas
Braço | Intervenção / tratamento |
---|---|
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. |
Critério de eleição
Idades qualificadas para estudar | 18 Years Para 18 Years |
Sexos elegíveis para estudo | All |
Aceita Voluntários Saudáveis | sim |
Critério | 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 |
Resultado
Medidas de Resultado Primário
1. Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale [6 weeks]
2. Odor (scored as no odor, odor on dressing change, odor all the time) [6 weeks]
3. Incidence of adverse events [6 weeks]
4. Braden Scale assessment [6 weeks]
5. Irritation [6 weeks]
6. Inflammation [6 weeks]
7. Pain [6 weeks]
Medidas de Resultado Secundário
1. Costs treated per ulcer [1 year]