Effect of Aloe Vera and Propolis on Wound Healing in Pressure Injuries

Pressure Ulcer Clinical Trial

Official title: Phd Candidate/Specialist Surgery Nurse

Status Completed

Clinical Trial Summary

This study was planned as an experimental study with a randomized control group to determine the effect of Aloe Vera and Propolis on wound healing in pressure injuries.

After receiving ethical approval, this study will take place between January 30, 2021 and January 30, 2022 in the General Intensive Care Unit of The Haydarpasa Numune Training and Research Hospital of the Istanbul Provincial Health Directorate, according to the criteria for inclusion and exclusion. The purpose of the research will be explained and it will be selected in accordance with the research criteria from individuals in the universe who have been granted permission by themselves or their guardians to participate in the post-information research. Within the scope of the planned study, an academic study containing aloe vera and propolis cream for patients with pressure injury and reporting the sample size to be used to determine the effect of the solution prepared by the researcher on wound healing (1) In the light of study , standard deviations for groups, respectively, in order to find a statistical difference of 20.4 days (50.5 days) from the 63.2 ± taken as the average wound healing time in pressure injuries; If 20,4 and 15 are taken, the effective sample size calculated for double-sided Student's t test for 0.05 error level and minimum 80% power is calculated as 33 for each group and a total of 66 patients will be admitted to the trial and control group. Patients who meet the study criteria will be distributed daily to experimental and control groups through a computerized randomization program.After randomization, in order to collect data, developed by the researcher in line with the relevant literature information; 'Patient Diagnostic Form', 'Braden Pressure Injury Risk Assessment Scale', 'Bates-Jensen Wound Assessment Tool' and 'Wound Surface 3D Assessment System (Ekare/inSight®)' will be used for wound measurement.In the collection of the data of the patients in the experimental and control group, the patient will be accepted according to the criteria of inclusion and exclusion in the research. 'Patient Diagnostic Form', 'Health History', 'Patient Measurements (Life Findings and Laboratory Findings)' will be questioned and recorded in the experimental and control group patients. The total scores of the test group patients will be recorded by performing a risk assessment with the pressure wound, 'Braden Pressure Injury Risk Assessment Scale'. With the 'Bates-Jensen Wound Assessment Tool', the physiological characteristics of the wound and the condition of the wound will be measured and recorded by performing wound staging. With ekare/inSight® device, wound staging will be performed by photographing the wound area, at the same time the healing status of the wound will be monitored and the reduction in wound volume, i.e. healing, will be observed. With ekare/inSight® device, the healing stages of the wound will be recorded. In the 'Braden Pressure Injury Risk Scale Assessment', the scores and total scores of the patients in the 'Braden Pressure Injury Risk Scale Assessment' will be recorded on the one day, the fourth day, the seventh day, the fourteenth day and twenty-first days by evaluating the substances 'emotional perception', 'humidity', 'activity', 'mobilization', 'nutrition', 'friction/tearing'. Pressure injury risk status and recovery status of the test and control group patients will be measured by Bates-Jensen scores and Braden scores and evaluated on the one day, fourth day, seventh day, fourteen days and twenty-first days. In addition, the date of the wound culture and wound culture results will be recorded as the wound healing time of the patients in the experimental and control group.

Clinical Trial Description

This research was planned as a randomized controlled experimental research to determine the effect of Aloe Vera and Propolis on wound healing in pressure injuries.

According to the European Pressure Injuries Advisory Panel (EPUAP) definition, pressure injuries alone are localized skin and/or subsurned tissue damage caused by pressure by pressure or tearing, usually occuring on bone protrusions (2).

Pressure injuries that we often encounter in the intensive care unit cause significant problems such as pain and discomfort, low movement and addiction in patients, increased mortality and morbidity, as well as a significant increase in the cost of health care in addition to loss of work and time (1).

Despite recent advances in wound care products, traditional treatments based on naturally sourced compounds such as plant extracts, honey and larvae remain important as alternative treatment options today. Today's trend is more towards the development of innovative wound care treatments, combining the use of traditional healing agents and modern products/applications.

In one study, they developed a transparent treatment by adding aloe vera to alginate hydrogels, propolis to dressing films, and layers of hydrogel containing honey (3). Studies have found that Aloe vera has an effect on the wound healing process as well as its antioxidant, antibacterial, antifungal, antiviral, and immunomodulatory effects. Anti-inflammatory and antimicrobial activities; It facilitates wound healing by stimulating cell proliferation, collagen synthesis and angiogenesis and accelerating wound contraction (3;4).

In the literature, it is mentioned that propolis has antioxidant, anti-inflammatory and antibacterial activity on wound healing within alternative treatment methods.

In a study conducted on experimental animals titled "Wound Healing Activity of Western Algerian Propolis", they formed three groups. In this study where the treatment period was 23 days, the percentage of wound closure was 94.93 ± 5.29% in the first group where propolis was applied, 79.97 ± 13.01% in the second group where a commercial cream was applied, and 72.55 ± 19.94% in the third group without any application. In addition, it was observed that the wound healed in 12 days in the first group, 16 days in the second group and 18 days in the third group. As a result of this study, it was found that the rate of recovery was higher and faster in the group treated with propolis (5).

In addition to studies examining the effectiveness of aloe vera and propolis separately on wound healing, in a study in which they were applied together, their study on 'Medicinal Plant Extracts and the Use of Wound Closure Substances', active ingredients of various herbs such as Propolis and Aloe vera in wound healing and tissue regeneration reported that it can be used to induce the process of wound closure and thus reduce the time to complete wound closure (7). In addition, it is stated in various studies and literature that Aloe vera and propolis may be effective in pressure injuries, which are of great importance in chronic wounds (3; 6; 7).

This study will set an example for pressure injuries with chronic wounds, speeding up the healing time of the patient's wound area, early discharge, reducing maintenance costs and other studies.In the light of these resources, the approval of the institution was obtained from the Istanbul Provincial Health Directorate and pilot work was started on 11.03.2021. Patients were randomized and the data collection phase started. ;

Related Conditions & MeSH terms

• Pressure Ulcer

• NCT number: NCT04942470
• Study type: Interventional
• Source: Haydarpasa Numune Training and Research Hospital
• Status: Completed
• Phase: N/A
• Start date: March 11, 2021
• Completion date: June 11, 2022