Ileostomy - Stoma Clinical Trial
— gAOVEstomaOfficial title:
Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene. Non-inferiority Randomised Controlled Clinical Trial. A Pilot Study.
Verified date | February 2023 |
Source | Universidad de Granada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario San Cecilio | Granada | |
Spain | Hospital Universitario Virgen de las Nieves | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada | NOTALIV cosmética natural, University of Jaén |
Spain,
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
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. |
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