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

Ileostomy - Stoma Clinical Trial

— gAOVEstoma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05289765
• Other study ID #: CEI-Granada-20/07/2021-7/21
• Status: Completed
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: June 20, 2022

Study information

• Verified date: February 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 20, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colostomy Stoma
• Ileostomy - Stoma
• Peristomal Skin Complication

Intervention

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.
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Universitario Virgen de las Nieves	Granada

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Granada	NOTALIV cosmética natural, University of Jaén

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 Tiss — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	Peristomal skin alterations	Any other chemical, infectious, mechanical, or immunological complications of interest	Change from baseline at 4 weeks and 8 weeks.
Primary	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	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.
Secondary	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.