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

Study Overview
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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.

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.

Official Title
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Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene. Non-inferiority Randomised Controlled Clinical Trial. A Pilot Study.

Conditions
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Colostomy Stoma, Ileostomy - Stoma, Peristomal Skin Complication

Intervention / Treatment
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* Other: A natural neutral Ecological Extra Virgin Olive Oil based gel
* Other: A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Ecological Extra Virgin Olive Oil | Other: A natural neutral Ecological Extra Virgin Olive Oil based gel<br>* 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.<br>|
| Active Comparator: Group 2<br>Conventional | Other: A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from DET (Discolouration, Erosion, Tissue overgrowth) in Peristomal Skin. | Discolouration, Erosion, Tissue overgrowth will be measured using the DET scale. DET scale examinates the peristomal skin based on the descriptions in affected area and severity of the three domains. Maximum points in each domain: 3 points for the size of the affected area and 2 points for the severity. First of all, the examiner assesses the size of the area affected in each of the three domains and score based on: 0 (Unaffected); 1 (<25%); 2 (25-50%); 3 (>50%). Then, the examiner assesses the severity in each of the three domains. Notes: If there is no discolouration then the skin is healthy - the area score is 0 and the total DET score must be 0. In a situation where a large area of skin with low severity includes a small area with a high severity, the highest severity should always be scored even though the area is small. Total score (maximum 15) is calculated by adding all of the subscores from each domain together. Higher scores mean a worse outcome. | Change from baseline at 4 weeks and 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat in Peristomal Skin. | Level of fat in skin will be collected by means of a digital skin detector. | Change from baseline at 4 weeks and 8 weeks. | 
| Skin moisture in Peristomal Skin. | Level of skin moisture will be collected by means of a digital skin detector. | Change from baseline at 4 weeks and 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colostomy, ileostomy, skin care, olive oil