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Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients

Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07537101
Acronym
APG-PI
Enrollment
40
Registered
2026-04-17
Start date
2026-06-05
Completion date
2027-04-20
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Injury

Brief summary

The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients. Does applying this natural gel reduce the incidence of pressure injuries compared to standard care? participants will be randomly assigned to either receive the gel application (Aloe Vera-Peppermint gel) or the standard hospital nursing care.

Interventions

COMBINATION_PRODUCTcombined Aloe Vera-Peppermint gel

Topical gel containing a combination of natural Aloe vera extract and peppermint oil. The intervention involves applying a thin layer of the gel to pressure-prone areas such as the sacrum and heels to prevent the development of pressure injuries. The application is performed twice daily during the patient's stay in the ICU.

Sponsors

Ali Abd-Alredha Hussein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. ICU patients aged 18 years or older. 2. Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization. 3. Unconsciousness, being under sedation or assisted ventilation. 4. Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13-14. 5. No Diarrhea, serum Albumin level below 3.5 g/dl, no edema. 6. No limit of changes in body position with multiple injuries. 7. Family consent to participate in the study. 8. The patient has no history of autoimmune diseases, renal failure, or diabetes, does not use immunosuppressive medications, and has no evidence of vascular disease. 9. All patients receiving standardized care (repositioning and pressure-relieving mattress).

Exclusion criteria

1. Family's unwillingness for the patient to continue participation 2. Sensitivity to Aloe Vera-Peppermint Gel after use on a patient's forearm (area of 2 × 2 cm) and this area was evaluated for the presence of redness, swelling and warmth within 45 min. 3. Spinal cord injury cases 4. death or patient transmission in less than 48 hrs. after admission to the ICU.

Design outcomes

Primary

MeasureTime frameDescription
incidence of pressure injuriesFrom the date of ICU admission until 10 daysThe number of participants who develop any new pressure injury during their ICU stay. Pressure injuries include Stage I, Stage II, Stage III, Stage IV, Unstageable, and Deep Tissue Pressure Injury, as defined by the National Pressure Injury Advisory Panel (NPIAP). Assessment will be performed daily by trained nursing staff using the Braden Scale and comprehensive clinical skin examination of pressure-prone areas.

Countries

Iraq

Contacts

CONTACTAli Abd-Alredha, master
Ali.hussein2102m@conursing.uobaghdad.edu.iq+9647700752984
STUDY_DIRECTORMohammed Baqer Al-Jubouri, PhD

University of Baghdad / College of Nursing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026