NCT05578638

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

Recruiting now NA Last updated 18 September 2024

What this trial tests

NA trial testing Aloe Vera rosemary tropical application in Pressure Injury in 128 participants. Currently enrolling.

Timeline

1 November 2022

Primary endpoint
30 April 2024

1 December 2024

Quick facts

Lead sponsor	Mansoura University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	128
Start date	1 November 2022
Primary completion	30 April 2024
Estimated completion	1 December 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Aloe Vera rosemary tropical application
• aloevera tropical application
• rosemary tropicalapplication

Conditions studied

• Pressure Injury — all drugs for Pressure Injury →

Sponsor

Mansoura University

Who can join

Adults 18 to 60, any sex, with Pressure Injury. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• incidence of stage 1 pressure ulcers
  Time frame: 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
  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 consi
• incidence of stage 1 pressure ulcers
  Time frame: 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
  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 consi
• incidence of stage 1 pressure ulcers
  Time frame: 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
  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 consi
• change in skin temperature at pressure points
  Time frame: will be measured at baseline and at the end of the study (after 10 days)
  Skin temperature will be measured using infrared thermometer
• change in pain level at pressure points
  Time frame: will be measured at baseline and at the end of the study (after 10 days)
  pain will be measured using 0-10 visual analogue scale

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dressings and topical agents for preventing pressure ulcers.
   Patton D, Moore ZE, Boland F, Chaboyer WP, et al · · 2024 · cited 5× · PMID 39625073 · DOI 10.1002/14651858.cd009362.pub4