Aloe vera gel versus olive oil for the prevention of pressure ulcers among bedridden patients
| ISRCTN | ISRCTN15691944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15691944 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Desh Bhagat University |
| Funder | Investigator initiated and funded |
- Submission date
- 16/07/2023
- Registration date
- 07/08/2023
- Last edited
- 08/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
This study aimed to compare the effects of aloe vera gel and olive oil in preventing pressure ulcers among bedridden individuals admitted in orthopaedic wards. Pressure ulcers are a prevalent issue in hospitals, leading to increased nursing care needs. Prior research suggests that aloe vera gel and olive oil can treat pressure ulcers by reducing bacterial presence and preserving skin integrity, making them potential preventive options.
Who can participate?
Patients aged 18 years or older admitted in the Orthopedics wards of selected hospitals who are at risk of pressure ulcers.
What does the study involve?
The study included two experimental groups and one control group in June 2022 to Feb 2023. The first experimental group received aloe vera gel, the second received olive oil, and the control group received routine skin care. The effectiveness of both treatments in preventing pressure ulcers was evaluated.
The assessment of pressure-prone areas was conducted over 11 days using the EPUAP and Braden scales.
What are the possible benefits and risks of participating?
Benefits include contributing to scientific knowledge, potential access to preventive treatments, medical monitoring, and potential skin health improvement. The study's findings may also improve patient care in the future. However, there are risks, such as adverse reactions to the substances, no guaranteed benefit, time commitment, discomfort, potential privacy concerns, and ethical considerations. Before joining, participants receive detailed information about the study, its objectives, potential risks, and benefits. Participation is voluntary and individuals can withdraw at any time without repercussions.
Where is the study run from?
Desh Bhagat University (India)
When is the study starting and how long is it expected to run for?
February 2021 to February 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Rajni Thapa, rajnithapa83@gmail.com
Contact information
Principal investigator
Shri Mata Vaishno Devi College of Nursing
Kakryal Katra Jammu
Landmark Smvd Narayana Super Speciality Hospita
Reasi District
Katra
182301
India
 ORCID ID |
0000-0002-0033-7522 |
|---|---|
| Phone | +91 (0)8825022259 |
| rajnithapa83@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomized clinical trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Effect of aloe vera gel versus olive oil for the prevention of pressure ulcers among bedridden patients |
| Study objectives | Aloe vera gel reduces the incidence of pressure ulcers. Olive oil reduces the incidence of pressure ulcers. |
| Ethics approval(s) |
1. Approved 23/06/2021, Ethical Committee Desh Bhagat University (Desh Bhagat University Punjab and GMC JAMMU, Jammu, 180003, India; +91 (0)9855007125; research@deshbhagatuniversity.in), ref: DBU/RC/872 2. Approved 04/06/2022, EC-GMC Jammu (Govt.Medical College & Hospital, Jammu, 180003, India; +91 (0)191-2584290, 91, 92 (Exchange); +91 (0)191-2582355, 56/ 2585444 (Control Room). +91 (0)191-2584234 ; pmc-gmcjammu@jk.gov.in), ref: GMC/2022/PhD/952 |
| Health condition(s) or problem(s) studied | Prevention of pressure ulcers among bed ridden patients admitted in orthopaedic ward |
| Intervention | A quasi-experimental study including two experimental and one control group aimed at preventing pressure ulcers. Aloe vera gel was applied to experimental group 1st and olive oil was applied topically to experimental group 2 while the control group received routine skin care. All three groups evaluated the effect of aloe vera gel and olive oil in the prevention of pressure ulcers. The assessment of the pressure-prone areas was performed over the course of 11 days using the Modified EPUAP (European Pressure Ulcer Advisory Panel) scale and the Braden Pressure Ulcer Risk Assessment scale. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Braden pressure ulcer risk reduction score as measured by the Braden Pressure ulcer risk assessment scale at 1st day pre-assessment and 1st day post-assessment |
| Key secondary outcome measure(s) |
Grade/type and location/site of pressure ulcer measured using the modified European Pressure Ulcer Advisory Panel (EPUAP) assessment scale assessed on the 11th day |
| Completion date | 10/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 232 |
| Total final enrolment | 210 |
| Key inclusion criteria | 1. Subjects admitted in the Orthopedics wards of selected hospitals. 2. Subjects within the 48 hours of hospitalization in the orthopaedics wards with no pressure ulcers. 3. Having moderate to high risk (9-14) Braden pressure ulcer score (NPUAP). 4. Subjects willing to participate. 5. Subjects insensitivity to topical Aloe Vera gel and Olive oil. 6. Subjects aged over 18 years. |
| Key exclusion criteria | 1. Subjects who were discharge in between the data collection phase. 2. Having Mild Braden Pressure ulcer risks. 3. Reluctance to continue cooperation |
| Date of first enrolment | 20/06/2022 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- India
Study participating centre
Bakshi Nagar
Jammu
180003
India
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request Rajni Thapa, rajnithapa83@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 08/03/2024 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 21/07/2023 | No | No |
Additional files
- 43964_PROTOCOL.pdf
- Protocol file
- ISRCTN15691944_BasicResults.pdf
- Basic results
Editorial Notes
08/03/2024: Basic results added as an additional file.
21/07/2023: Study's existence confirmed by Ethical Committee Desh Bhagat University.
