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

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

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma; Peristomal Skin Complication; Colostomy Stoma
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Granada, Spain, 18016
    • Hospital Universitario San Cecilio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Ecological Extra Virgin Olive Oil	Other: 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.
Active Comparator: Group 2; Conventional	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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception about stoma self-care.	Two indicators of the outcome "Self-care of the ostomy [1615]" from Nursing Outcome Classification (NOC) will be used: "Appears comfortable viewing stoma [161503]" and "Expresses acceptance of ostomy [161519]". Both indicators are measured using a Likert scale from 1 to 5. Higher scores mean a better outcome.	Change from baseline at 4 weeks and 8 weeks.
Questionnaire to evaluate difficulty in placing and removing the device/bag	The questionnaire include two items with dichotomous answer (Yes/No). These items asseses the difficulty in placing and removing the device/bag on the peristomal skin in relation to the correct use of the adhesive included in these devices. Additionally, other problems reported by the patients in placing and removing the device/bag will be collected.	Change from baseline at 4 weeks and 8 weeks.
Local reactions in stoma or peristomal skin	Local reactions such as itching, pain, or stinging. A visual analogue scale from 0 to 10 (score) will be used. Higher scores mean a worse outcome.	Change from baseline at 4 weeks and 8 weeks.
Peristomal skin alterations	Any other chemical, infectious, mechanical, or immunological complications of interest	Change from baseline at 4 weeks and 8 weeks.

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Collaborators: University of Jaen; NOTALIV cosmética natural
• Investigators: Principal Investigator: César Hueso Montoro, PhD, Department of Nursing, University of Granada, Granada, Spain; Principal Investigator: Concepción Capilla Díaz, PhD, Department of Nursing, University of Granada, Granada, Spain; Principal Investigator: Francisco Pedro García Fernández, PhD, Department of Nursing, University of Jaén, Jaén, Spain

Publications and helpful links

General Publications

• 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 Feb 11:S0965-206X(23)00016-5. doi: 10.1016/j.jtv.2023.02.004. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): May 6, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: ileostomy; colostomy; olive oil; skin care
• Other Study ID Numbers: CEI-Granada-20/07/2021-7/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sets will be shared that underlie results in a publication
• IPD Sharing Time Frame: December 2022
• IPD Sharing Access Criteria: Data set underlie results in a publication will be made available by the authors, without undue reservation
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No