Status:
COMPLETED
Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene
Lead Sponsor:
Universidad de Granada
Collaborating Sponsors:
University of Jaén
NOTALIV cosmética natural
Conditions:
Colostomy Stoma
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the efficacy of the application of a neutral gel based on ecological extra virgin olive oil for peristomal skin hygiene in individuals with colostomy and ileostomy.
Detailed Description
This is a non-inferiority randomised controlled clinical trial conducted with parallel groups as a pilot study. The main aim of this research is to evaluate the efficacy of the application of an Ecolo...
Eligibility Criteria
Inclusion
- Individuals with a colostomy or ileostomy.
- Individuals using one- or two-piece devices.
- Individuals demonstrating knowledge and skills in stoma self-care. The criterion is to score between 4 and 5 on the following stoma hygiene-related indicators of the Nursing Outcomes Classification (NOC): "Knowledge: ostomy care \[1829\]" and "Self-care of the ostomy \[1615\]".
- Individuals agreeing to participate in the study
Exclusion
- Individuals with involvement of the peristomal skin area as measured by the DET scale with a score of at least 1 in one of the three evaluation domains (less than 25% involvement).
- Individuals undergoing treatment for the condition that led to their ostomy as this may affect the condition of the skin.
- Terminally ill persons.
- Individuals with a known allergy to any of the gel components, both in the experimental group and in the active control group.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05289765
Start Date
February 22 2022
End Date
June 20 2022
Last Update
February 28 2023
Active Locations (2)
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1
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
2
Hospital Universitario San Cecilio
Granada, Spain, 18016