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

Pressure Ulcer Clinical Trial

Official title:

Phd Candidate/Specialist Surgery Nurse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942470
• Other study ID #: OAydemir1673348861.
• Secondary ID: PHD Candidate
• Status: Completed
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: June 11, 2022

Study information

• Verified date: August 2022
• Source: Haydarpasa Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To agree verbally and in writing to participate in the research by himself or his legal guardian after the information for the research,

• Being 18 years of age or older,

• During the pressure wound stages of the participant in the study; Patients with stage II-III pressure sores

• The patients with iskial, sacral, thoracenthers, shoulder, dorsal, heel, malleos, pretibial, elbows, scapula, occiputal, the other regions that may form pressure injury to the body will be included in the study.

Exclusion Criteria:

• Those who have an allergic reaction to the solution to be applied,

• Individuals under the age of 18,

• Patients with Stage Ive IV pressure sores,

• If the patient is included in the study, it will be left out of the study if it loses life during the twenty-day period.

• Patients who do not agree to participate in the research verbally and in writing by themselves or their legal guardian after the information for the research will be excluded from the research.

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

Other:
• Aloe vera and propolis applied
Suitable of sterile pads containing aloe vera and propolis to the area with pressure sores

Locations

Country	Name	City	State
Turkey	Bahcelievler State Hospital	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital	Istanbul
Turkey	Medipol Üniversity	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital	Üsküdar	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Haydarpasa Numune Training and Research Hospital	Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Avijgan M, Kamran A, Abedini A. Effectiveness of Aloe Vera Gel in Chronic Ulcers in Comparison with Conventional Treatments. Iran J Med Sci. 2016 May;41(3 Suppl):S30. — View Citation

Khorasani G, Ahmadi A, Jalal Hosseinimehr S, Ahmadi A, Taheri A, Fathi H. The Effects of Aloe Vera Cream on Split-thickness Skin Graft Donor Site Management: A Randomized, Blinded, Placebo-controlled Study . Wounds. 2011 Feb;23(2):44-8. — View Citation

Medellín-Luna MF, Castañeda-Delgado JE, Martínez-Balderas VY, Cervantes-Villagrana AR. Medicinal Plant Extracts and Their Use As Wound Closure Inducing Agents. J Med Food. 2019 May;22(5):435-443. doi: 10.1089/jmf.2018.0145. Epub 2019 Apr 3. Review. — View Citation

Pereira RF, Bártolo PJ. Traditional Therapies for Skin Wound Healing. Adv Wound Care (New Rochelle). 2016 May 1;5(5):208-229. Review. — View Citation

Singh S, Gupta A, Gupta B. Scar free healing mediated by the release of aloe vera and manuka honey from dextran bionanocomposite wound dressings. Int J Biol Macromol. 2018 Dec;120(Pt B):1581-1590. doi: 10.1016/j.ijbiomac.2018.09.124. Epub 2018 Sep 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Braden Pressure Injury Risk Scale Assessment	Braden Pressure Injury Risk Scale Assessment	Day one scores
Primary	Braden Pressure Injury Risk Scale Assessment	Braden Pressure Injury Risk Scale Assessment	Fourth day scores
Primary	Braden Pressure Injury Risk Scale Assessment	Braden Pressure Injury Risk Scale Assessment	Seventh day scores
Primary	Braden Pressure Injury Risk Scale Assessment	Braden Pressure Injury Risk Scale Assessment	Fourteenth day scores
Primary	Braden Pressure Injury Risk Scale Assessment	Braden Pressure Injury Risk Scale Assessment	Twenty-first day scores
Primary	Bates-Jensen Wound Assessment Tool Scores	Bates-Jensen Wound Assessment Tool Scores	Day one scores
Primary	Bates-Jensen Wound Assessment Tool Scores	Bates-Jensen Wound Assessment Tool Scores	Fourth day scores
Primary	Bates-Jensen Wound Assessment Tool Scores	Bates-Jensen Wound Assessment Tool Scores	Seventh day scores
Primary	Bates-Jensen Wound Assessment Tool Scores	Bates-Jensen Wound Assessment Tool Scores	Fourteenth day scores
Primary	Bates-Jensen Wound Assessment Tool Scores	Bates-Jensen Wound Assessment Tool Scores	Twenty-first day scores
Primary	Patient Measurements (Life Findings, Laboratory Values)	Hemoglobin measurement results (g/dL)	Day one hemoglobin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Hemoglobin measurement results (g/dL)	Fourth day hemoglobin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Hemoglobin measurement results (g/dL)	Seventh day hemoglobin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Hemoglobin measurement results (g/dL)	Fourteenth day hemoglobin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Hemoglobin measurement results (g/dL)	Twenty-first day hemoglobin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Albumin measurement results (g/dL)	Day one albumin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Albumin measurement results (g/dL)	Seventh day albumin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Albumin measurement results (g/dL)	Fourteenth day albumin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Albumin measurement results (g/dL)	Twenty-first day albumin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pre-albumin measurement results (g/dL)	Day one pre-albumin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pre-albumin measurement results (g/dL)	Seventh day pre-albumin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pre-albumin measurement results (g/dL)	Fourteenth day pre-albumin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pre-albumin measurement results (g/dL)	Twenty-first day pre-albumin measurement results (g/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Glucose measurement results (mg/dL)	Day one glucose measurement results (mg/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Glucose measurement results (mg/dL)	Fourth day glucose measurement results (mg/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Glucose measurement results (mg/dL)	Seventh day glucose measurement results (mg/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Glucose measurement results (mg/dL)	Fourteenth day glucose measurement results (mg/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Glucose measurement results (mg/dL)	Twenty-first day glucose measurement results (mg/dL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Leukocyte measurement results (10^3/uL)	Day one leukocyte measurement results (10^3/uL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Leukocyte measurement results (10^3/uL)	Fourth day leukocyte measurement results (10^3/uL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Leukocyte measurement results (10^3/uL)	Seventh day leukocyte measurement results (10^3/uL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Leukocyte measurement results (10^3/uL)	Fourteenth day leukocyte measurement results (10^3/uL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Leukocyte measurement results (10^3/uL)	Twenty-first day leukocyte measurement results (10^3/uL)
Primary	Patient Measurements (Life Findings, Laboratory Values)	SaO2 measurement results (%)	Day one SaO2 measurement results (%)
Primary	Patient Measurements (Life Findings, Laboratory Values)	SaO2 measurement results (%)	Fourth day SaO2 measurement results (%)
Primary	Patient Measurements (Life Findings, Laboratory Values)	SaO2 measurement results (%)	Seventh day SaO2 measurement results (%)
Primary	Patient Measurements (Life Findings, Laboratory Values)	SaO2 measurement results (%)	Fourteenth day SaO2 measurement results (%)
Primary	Patient Measurements (Life Findings, Laboratory Values)	SaO2 measurement results (%)	Twenty-first day SaO2 measurement results (%)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Body Temperature measurement results (degrees centigrade)	Day one body temperature measurement results (degrees centigrade)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Body Temperature measurement results (degrees centigrade)	Fourth day body temperature measurement results (degrees centigrade)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Body Temperature measurement results (degrees centigrade)	Seventh day body temperature measurement results (degrees centigrade)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Body Temperature measurement results (degrees centigrade)	Fourteenth day body temperature measurement results (degrees centigrade)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Body Temperature measurement results (degrees centigrade)	Twenty-first day body temperature measurement results (degrees centigrade)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Respiratory rate measurement results (.../dak)	Day one respiratory rate measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Respiratory rate measurement results (.../dak)	Fourth day respiratory rate measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Respiratory rate measurement results (.../dak)	Seventh day respiratory rate measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Respiratory rate measurement results (.../dak)	Fourteenth day respiratory rate measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Respiratory rate measurement results (.../dak)	Twenty-first day respiratory rate measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pulse measurement results (.../dak)	Day one pulse measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pulse measurement results (.../dak)	Fourth day pulse measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pulse measurement results (.../dak)	Seventh day pulse measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pulse measurement results (.../dak)	Fourteenth day pulse measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Pulse measurement results (.../dak)	Twenty-first day pulse measurement results (.../dak)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Blood Plessure measurement results (mmHg)	Day one blood plessure measurement results (mmHg)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Blood Plessure measurement results (mmHg)	Fourth day blood plessure measurement results (mmHg)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Blood Plessure measurement results (mmHg)	Seventh day blood plessure measurement results (mmHg)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Blood Plessure measurement results (mmHg)	Fourteenth day blood plessure measurement results (mmHg)
Primary	Patient Measurements (Life Findings, Laboratory Values)	Blood Plessure measurement results (mmHg)	Twenty-first day blood plessure measurement results (mmHg)
Primary	Aloe Vera and Propolis Applied Experimental Group and Control Group, Bates-Jensen Wound Assessment Tool Scores	Aloe Vera and Propolis Applied Experimental Group and Control Group, Bates-Jensen Wound Assessment Tool Scores	Score change results between day one and day twenty
Primary	Aloe Vera and Propolis Applied Experimental Group and Control Group, Braden Pressure Injury Risk Scale Assessment Scores	Aloe Vera and Propolis Applied Experimental Group and Control Group, Braden Pressure Injury Risk Scale Assessment Scores	Score change results between day one and day twenty
Primary	Pressure Wound Recovery Time(Day)	Pressure Wound Recovery Time(Day)	It will be recorded on which day the wound healed within three weeks.
Primary	The date the wound culture was taken	It will be recorded as the date (day / month / year) of the wound culture.	For up to three weeks, deep tissue wound culture results will be recorded as (day/month/year).
Primary	Wound culture results	The infectious agent growing in the wound culture (Deep tissue culture) will be recorded.	Culture results for three weeks will be recorded.
Primary	Socio-demographic characteristics of the patient	Socio-demographic characteristics of the patient	Sociodemographic characteristics of patients will be recorded for up to three weeks.
Primary	Patient health history	Patient health history	This outcome measure includes the patient's health history of existing chronic diseases and any co-morbidities developed during the three-week study period.
Primary	Height, Weight	Height .... cm or Weight .... kg	This outcome measure will be used to calculate the patient's body mass index by recording the three-week height and weight measurement results and weight changes over the study period.
Primary	Body Mass Indeks	kg/m2	This outcome measure will be used to calculate the patient's body mass index by recording the three-week height and weight measurement results and weight changes over the study period.
Primary	Current disease information and medications used	Current disease information and medications used	This outcome measure includes the patient's current chronic disease-related health history, medications used and any comorbidities developed during the three-week study period, and information on medications used during that three-week period.

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