Colostomy StomagAOVEstomaNCT05289765
Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene
A study testing A natural neutral Ecological Extra Virgin Olive Oil based gel and A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products in people with Colostomy Stoma and Ileostomy - Stoma, run by Universidad de Granada at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy Stoma, Ileostomy - Stoma, Peristomal Skin Complication
- What is being tested?
- A natural neutral Ecological Extra Virgin Olive Oil based gel and A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesSpain
- Study dates
- 22 Feb 2022to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario San Cecilio
Granada, 18016
About this study
Official title: 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.
Read the 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.
- Being tested
- A natural neutral Ecological Extra Virgin Olive Oil based gel, A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products
- Keywords
- colostomy, ileostomy, skin care, olive oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A natural neutral Ecological Extra Virgin Olive Oil based gelOther
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 productsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Ecological Extra Virgin Olive Oil Receives: Other: A natural neutral Ecological Extra Virgin Olive Oil based gel |
| Group 2 | Active comparator | Conventional Receives: Other: A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 4 weeks and 8 weeks.
Secondary outcomes (2)
Fat in Peristomal Skin.
Level of fat in skin will be collected by means of a digital skin detector.
Measured: 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.
Measured: Change from baseline at 4 weeks and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start22 Feb 2022
- Primary completion6 May 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colostomy StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jaén, NOTALIV cosmética natural
- Responsible party
- Principal investigator, César Hueso-Montoro, Universidad de Granada
- Investigators
- César Hueso Montoro, PhD, Principal investigator, Department of Nursing, University of Granada, Granada, SpainConcepción Capilla Díaz, PhD, Principal investigator, Department of Nursing, University of Granada, Granada, SpainFrancisco Pedro García Fernández, PhD, Principal investigator, Department of Nursing, University of Jaén, Jaén, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289765
- Sponsor's protocol ID
- CEI-Granada-20/07/2021-7/21
- Acronym
- gAOVEstoma
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sets will be shared that underlie results in a publication
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 May;32(2):188-193. doi: 10.1016/j.jtv.2023.02.004. Epub 2023 Feb 11.
PubMed 36801121
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene. Non-inferiority Randomised Controlled Clinical Trial. A Pilot Study.
- ClinicalTrials.gov ID
- NCT05289765
- Acronym / sponsor ID
- gAOVEstoma / CEI-Granada-20/07/2021-7/21
- Keywords
- colostomy, ileostomy, skin care, olive oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University of Jaén, NOTALIV cosmética natural
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: A natural neutral Ecological Extra Virgin Olive Oil based gelEcological Extra Virgin Olive Oil |
| Group 2 | Active comparator | Other: A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived productsConventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A natural neutral Ecological Extra Virgin Olive Oil based gelA 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. | Other | Group 1 |
| A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived productsA 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 | Other | Group 2 |
Primary outcome
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.
2 secondary outcomes
Fat in Peristomal Skin.
Time frame: Change from baseline at 4 weeks and 8 weeks.
Skin moisture in Peristomal Skin.
Time frame: Change from baseline at 4 weeks and 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Results publication: PubMed 36801121Hueso-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 May;32(2):188-193. doi: 10.1016/j.jtv.2023.02.004. Epub 2023 Feb 11.
- Individual participant dataSharing planned: Yes. Data sets will be shared that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
César Hueso Montoro, PhD principal investigator
Department of Nursing, University of Granada, Granada, Spain
Concepción Capilla Díaz, PhD principal investigator
Department of Nursing, University of Granada, Granada, Spain
Francisco Pedro García Fernández, PhD principal investigator
Department of Nursing, University of Jaén, Jaén, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A natural neutral Ecological Extra Virgin Olive Oil based gel and A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products in people with Colostomy Stoma and Ileostomy - Stoma, run by Universidad de Granada at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from DET (Discolouration, Erosion, Tissue overgrowth) in Peristomal Skin. (time frame: Change from baseline at 4 weeks and 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.