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

NCT07537101 — Not applicable, Not yet recruiting, 40 participants, Ali Abd-Alredha Hussein

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07537101, acronym APG-PI
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	40 (Estimated)
Sponsor	Ali Abd-Alredha Hussein (Other)
Conditions	Pressure Injury
Interventions	combined Aloe Vera-Peppermint gel (Combination product)
Dates	start 2026-06-05 (estimated), primary completion 2026-12-28 (estimated), completion 2027-04-20 (estimated), first posted 2026-04-17, last updated 2026-04-30
Locations	1 site in Iraq

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
experimental group	Experimental	Combination Product: combined Aloe Vera-Peppermint gel	Patients in this group will receive a topical application of the combined Aloe Vera-Peppermint gel on pressure-prone areas. The gel will be applied twice daily, in addition to the standard nursing care protocol for pressure injury prevention.
control group	No intervention		Patients in this group will receive the standard nursing care protocol for pressure injury prevention as practiced in the ICU, which includes regular repositioning, skin assessment, cleansing, moisturizing, and use of pressure-relieving devices. No experimental Aloe Vera-Peppermint gel will be applied to this group.

combined Aloe Vera-Peppermint gel (Combination product): 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.

+Outcome measures

Primary outcomes

incidence of pressure injuries [From the date of ICU admission until 10 days]: The 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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Baqubah Teaching Hospital	Baqubah, Diyala Governorate	Iraq

+Investigators

Mohammed Baqer Al-Jubouri, PhD, Study director, University of Baghdad / College of Nursing