Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID05578638

A Randomized Prospective Clinical Study on the Effect of Aloe Vera Gel and Rosemary Oil for Skin Ulcer Protection in Orthopedic Wards

Led by Mansoura University · Updated on 2024-09-20

128

Participants Needed

1

Research Sites

30 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Aloe Vera gel and Rosemary oil in preventing pressure injuries in patients admitted to orthopedic wards, who are at risk of developing pressure ulcers. This study focuses on comparing the skin-protective properties of these medicinal plants, known for their antioxidant and anti-inflammatory effects, to reduce skin ulcers and pain. The trial is a randomized, triple-masked clinical study sponsored by Mansoura University. Participants will be assigned to one of four groups: Aloe Vera gel, Rosemary oil, a combined Aloe Vera and Rosemary spray, or a control group with no intervention. Each treatment involves rubbing 10 ml of the assigned spray twice daily on areas at risk for pressure injuries, including the sacrum, hips, and heels, over a period of 10 days. The study aims to observe differences in pressure injury development among these groups. During the study, patients will be monitored daily by trained nurses and specialists for the presence of stage 1 pressure ulcers on days 3, 7, and 10 at 9:00 am. Researchers will also measure changes in skin temperature and pain levels at pressure points before and after the 10-day intervention. Participants are expected to remain in the study for at least 10 days to complete the treatment and assessments.

CONDITIONS

Brief Title

Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to participate in the research
  • No skin diseases such as psoriasis, fungal illness, or freckles
  • Patients at risk of moderate to severe bedsores based on nursing diagnosis and Braden score less than 13-14
  • No pressure injuries present upon admission
  • Expected hospital stay longer than 10 days
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

  • Hemoglobin levels dropping below 12 mg/dl in men or below 10 mg/dl in women during the study
  • Anemia
  • Hyperthermia during the study
  • Sensitivity or allergy to Aloe Vera or Rosemary

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 days

Participants apply 10 ml of Aloe Vera spray, Rosemary spray, or a combination of both twice daily to areas at risk for pressure injuries including the sacrum, hips, and heels.

Daily skin care application visits for 10 days

Follow-up

Duration - 10 days

Participants are evaluated by trained nurses and specialists at day 3, day 7, and day 10 after starting treatment to check for the presence of stage 1 pressure ulcers and changes in skin temperature and pain at pressure points.

3 visits (in-person) on day 3, day 7, and day 10

Trial Site Locations

Total: 1 location

1

Faculty of Nursing Mansoura University

Al Mansurah, Egypt

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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