Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2022-06-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colostomy Stoma Ileostomy - Stoma Peristomal Skin Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1

Ecological Extra Virgin Olive Oil

Group Type EXPERIMENTAL

A natural neutral Ecological Extra Virgin Olive Oil based gel

Intervention Type OTHER

A natural neutral Ecological Extra Virgin Olive Oil based gel will be applied to the peristomal skin area at the time of peristomal skin care. Hygiene shall be performed by patients themselves following a standardised procedure recommended by Clinical Guideline.

Group 2

Conventional

Group Type ACTIVE_COMPARATOR

A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products

Intervention Type OTHER

A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products will be applied to the peristomal skin area at the time of peristomal skin care. Hygiene shall be performed by patients themselves following a standardised procedure recommended by Clinical Guideline

Interventions

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A natural neutral Ecological Extra Virgin Olive Oil based gel

A natural neutral Ecological Extra Virgin Olive Oil based gel will be applied to the peristomal skin area at the time of peristomal skin care. Hygiene shall be performed by patients themselves following a standardised procedure recommended by Clinical Guideline.

Intervention Type OTHER

A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products

A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products will be applied to the peristomal skin area at the time of peristomal skin care. Hygiene shall be performed by patients themselves following a standardised procedure recommended by Clinical Guideline

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No