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

NCT05289765 | Completed

• 1 other identifier: CEI-Granada-20/07/2021-7/21
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colostomy Stoma; Ileostomy - Stoma; Peristomal Skin Complication

Keywords

colostomy; ileostomy; skin care; olive oil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fat in Peristomal Skin.

  Change from baseline at 4 weeks and 8 weeks.

• Skin moisture in Peristomal Skin.

  Change from baseline at 4 weeks and 8 weeks.

Other Outcomes (4)

• Perception about stoma self-care.

  Change from baseline at 4 weeks and 8 weeks.

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

  Change from baseline at 4 weeks and 8 weeks.

• Local reactions in stoma or peristomal skin

  Change from baseline at 4 weeks and 8 weeks.

Study Arms (2)

Group 1

EXPERIMENTAL

Ecological Extra Virgin Olive Oil

Other: A natural neutral Ecological Extra Virgin Olive Oil based gel

Group 2

ACTIVE COMPARATOR

Conventional

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

Interventions

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.

Group 1

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• University of Jaén: collaborator
• NOTALIV cosmética natural: collaborator

Study Sites (2)

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Related 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 Tissue Viability. 2023 May;32(2):188-193. doi: 10.1016/j.jtv.2023.02.004. Epub 2023 Feb 11.

  PMID: 36801121 RESULT

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 21, 2022
• Study Start: February 22, 2022
• Primary Completion: May 6, 2022
• Study Completion: June 20, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: December 2022
• Access Criteria: Data set underlie results in a publication will be made available by the authors, without undue reservation

Locations

ES (2)