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

NCT07537101 | Not Yet Recruiting

• 1 other identifier: 94
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury

Outcome Measures

Primary Outcomes (1)

• incidence of pressure injuries

  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.

  From the date of ICU admission until 10 days

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Combination Product: combined Aloe Vera-Peppermint gel

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.

Interventions

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.

experimental group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Family's unwillingness for the patient to continue participation
• 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.
• Spinal cord injury cases
• death or patient transmission in less than 48 hrs. after admission to the ICU.

Sponsors & Collaborators

• Ali Abd-Alredha Hussein: lead

Study Sites (1)

Baqubah Teaching Hospital

Baqubah, Diyala Governorate, Iraq

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mohammed Baqer Al-Jubouri, PhD

  University of Baghdad / College of Nursing

  STUDY DIRECTOR

Central Study Contacts

Ali Abd-Alredha, master

CONTACT

+9647700752984; Ali.hussein2102m@conursing.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ph.D candidate

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): April 20, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)