Clinical trial NCT05289765: Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene
Official title: Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene. Non-inferiority Randomised Controlled Clinical Trial. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colostomy Stoma
Ileostomy - Stoma
Peristomal Skin Complication
Keywords: colostomy
ileostomy
skin care
olive oil
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University of Jaén
name: NOTALIV cosmética natural
First posted: 2022-03-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 Ecological Extra Virgin Olive Oil (eEVOO) neutral gel in peristomal skin hygiene in individuals with colostomy and ileostomy compared to the application of a neutral gel without eEVOO or any other olive oil-derived products. The specific objective is to determine the safety of the application of this gel in terms of the absence of adverse effects upon placement and removal of the device/bag and peristomal skin complications.

The setting are the Stoma care unit at the Virgen de las Nieves University Hospital and the San Cecilio University Hospital (Granada, Spain).

The response variable will be measured using the DET scale, which assesses tissue colouration, integrity, and overgrowth in peristomal skin. Skin moisture and fat will also be measured, as well as the individuals' perceptions of their stoma.The safety of the intervention will be determined by the absence of adverse effects at different levels: Difficulty in placing and removing the device/bag; Local reactions such as itching, pain, or stinging. A visual analogue scale will be used; Any other chemical, infectious, mechanical, or immunological complications of interest.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change from DET (Discolouration, Erosion, Tissue overgrowth) in Peristomal Skin.
timeFrame: Change from baseline at 4 weeks and 8 weeks.
Secondary outcomes:
measure: Fat in Peristomal Skin.
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Skin moisture in Peristomal Skin.
timeFrame: Change from baseline at 4 weeks and 8 weeks.
Other outcomes:
measure: Perception about stoma self-care.
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Questionnaire to evaluate difficulty in placing and removing the device/bag
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Local reactions in stoma or peristomal skin
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Peristomal skin alterations
timeFrame: Change from baseline at 4 weeks and 8 weeks.
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
Study officials:
affiliation: Department of Nursing, University of Granada, Granada, Spain
name: César Hueso Montoro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nursing, University of Granada, Granada, Spain
name: Concepción Capilla Díaz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nursing, University of Jaén, Jaén, Spain
name: Francisco Pedro García Fernández, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hueso-Montoro C, Moya-Munoz N, Martin-Cebrian J, Huertas-Fernandez R, Sanchez-Crisol I, Garcia-Fernandez FP, Capilla-Diaz C. Efficacy of gel containing organic extra virgin olive oil for peristomal skin hygiene: A pilot randomised controlled trial. J Tissue Viability. 2023 May;32(2):188-193. doi: 10.1016/j.jtv.2023.02.004. Epub 2023 Feb 11.