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Completed

NCT Number: NCT05289765

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

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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Key information

Conditions

Colostomy Stoma Ileostomy - Stoma Peristomal Skin Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario San Cecilio, Granada, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A natural neutral Ecological Extra Virgin Olive Oil based gel

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.

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

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

Primary outcomes

  1. Change from DET (Discolouration, Erosion, Tissue overgrowth) in Peristomal Skin.

    Time frame: Change from baseline at 4 weeks and 8 weeks.

    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.

Secondary outcomes

  1. Fat in Peristomal Skin.

    Time frame: Change from baseline at 4 weeks and 8 weeks.

    Level of fat in skin will be collected by means of a digital skin detector.

  2. Skin moisture in Peristomal Skin.

    Time frame: Change from baseline at 4 weeks and 8 weeks.

    Level of skin moisture will be collected by means of a digital skin detector.

Other outcomes

  1. Perception about stoma self-care.

    Time frame: Change from baseline at 4 weeks and 8 weeks.

    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.

  2. Questionnaire to evaluate difficulty in placing and removing the device/bag

    Time frame: Change from baseline at 4 weeks and 8 weeks.

    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.

  3. Local reactions in stoma or peristomal skin

    Time frame: Change from baseline at 4 weeks and 8 weeks.

    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.

  4. Peristomal skin alterations

    Time frame: Change from baseline at 4 weeks and 8 weeks.

    Any other chemical, infectious, mechanical, or immunological complications of interest

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • NOTALIV cosmética natural
  • University of Jaén

Registry information

Official study title

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

Acronym: gAOVEstoma

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2022
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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