Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

NCT05578638 | Recruiting

• 1 other identifier: mans u
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Most patients admitted to the orthopedic ward are at risk of developing pressure ulcers. Today, the tendency to use medicinal herbs in pressure ulcer treatment has increased due to the variety of effective compounds and their fewer side effects.

Conditions

Pressure Injury

Outcome Measures

Primary Outcomes (5)

• incidence of stage 1 pressure ulcers

  The NPUAP scale is staging system since 1989 as one of the most widely used classification systems for the PI that describes the depth of the wound caused by PIs. In accordance with the panel, the PIs are divided into the original 4 stages and adding 2 stages on deep tissue injury and unstageable PIs. In this work, skin redness without discoloration by finger pressure in area of interest was considered as PIs stage I

  Before applying sprays, Patients will be evaluated by pairs of observers (trained nurse and specialist) at 9:00 am for the presence of PIs at third day, after intervention

• incidence of stage 1 pressure ulcers

  The NPUAP scale is staging system since 1989 as one of the most widely used classification systems for the PI that describes the depth of the wound caused by PIs. In accordance with the panel, the PIs are divided into the original 4 stages and adding 2 stages on deep tissue injury and unstageable PIs. In this work, skin redness without discoloration by finger pressure in area of interest was considered as PIs stage I

  Before applying sprays, Patients will be evaluated by pairs of observers (trained nurse and specialist) at 9:00 am for the presence of PIs at seventh day, after intervention

• incidence of stage 1 pressure ulcers

  The NPUAP scale is staging system since 1989 as one of the most widely used classification systems for the PI that describes the depth of the wound caused by PIs. In accordance with the panel, the PIs are divided into the original 4 stages and adding 2 stages on deep tissue injury and unstageable PIs. In this work, skin redness without discoloration by finger pressure in area of interest was considered as PIs stage I

  Before applying sprays, Patients will be evaluated by pairs of observers (trained nurse and specialist) at 9:00 am for the presence of PIs at the tenth day, after intervention

• change in skin temperature at pressure points

  Skin temperature will be measured using infrared thermometer

  will be measured at baseline and at the end of the study (after 10 days)

• change in pain level at pressure points

  pain will be measured using 0-10 visual analogue scale

  will be measured at baseline and at the end of the study (after 10 days)

Study Arms (4)

aloe Vera group

EXPERIMENTAL

10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

Combination Product: aloevera tropical application

rosemary group

EXPERIMENTAL

10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

Combination Product: rosemary tropicalapplication

aloe Vera rosemary compound

EXPERIMENTAL

10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

Combination Product: Aloe Vera rosemary tropical application

control group

NO INTERVENTION

Interventions

Aloe Vera rosemary tropical application COMBINATION_PRODUCT

10 ml of the Aloe Vera rosemary spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

aloe Vera rosemary compound

aloevera tropical application COMBINATION_PRODUCT

10 ml of the Aloe Vera spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

aloe Vera group

rosemary tropicalapplication COMBINATION_PRODUCT

10 ml of the rosemary spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

rosemary group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• willingness to participate in research, lack of skin diseases (such as psoriasis, fungal illness, freckles), patients that are at risk of moderate to severe bedsores according to nursing diagnosis and Braden scoring tool and scored less than 13-14; the absence of PI on admission; the probability of length of stay should be above 10 days

You may not qualify if:

• a decrease in hemoglobin levels during the study to lower than 12 in men and less than 10 mg/dl in women, anemia, hyperthermia during the study and sensitivity to Aloe Vera or Rosemary.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Nursing Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at medical surgical nursing

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 13, 2022
• Study Start: November 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: December 1, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)