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

NCT04942470 | Completed DMC

• 2 other identifiers: OAydemir1673348861.PHD Candidate
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pressure Ulcer

Keywords

Aloe Vera; Propolis; Pressure ulcer prevention; Nursing care; Treatment

Outcome Measures

Primary Outcomes (68)

• Braden Pressure Injury Risk Scale Assessment

  Braden Pressure Injury Risk Scale Assessment

  Day one scores

• Braden Pressure Injury Risk Scale Assessment

  Braden Pressure Injury Risk Scale Assessment

  Fourth day scores

• Braden Pressure Injury Risk Scale Assessment

  Braden Pressure Injury Risk Scale Assessment

  Seventh day scores

• Braden Pressure Injury Risk Scale Assessment

  Braden Pressure Injury Risk Scale Assessment

  Fourteenth day scores

• Braden Pressure Injury Risk Scale Assessment

  Braden Pressure Injury Risk Scale Assessment

  Twenty-first day scores

• Bates-Jensen Wound Assessment Tool Scores

  Bates-Jensen Wound Assessment Tool Scores

  Day one scores

• Bates-Jensen Wound Assessment Tool Scores

  Bates-Jensen Wound Assessment Tool Scores

  Fourth day scores

• Bates-Jensen Wound Assessment Tool Scores

  Bates-Jensen Wound Assessment Tool Scores

  Seventh day scores

• Bates-Jensen Wound Assessment Tool Scores

  Bates-Jensen Wound Assessment Tool Scores

  Fourteenth day scores

• Bates-Jensen Wound Assessment Tool Scores

  Bates-Jensen Wound Assessment Tool Scores

  Twenty-first day scores

• Patient Measurements (Life Findings, Laboratory Values)

  Hemoglobin measurement results (g/dL)

  Day one hemoglobin measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Hemoglobin measurement results (g/dL)

  Fourth day hemoglobin measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Hemoglobin measurement results (g/dL)

  Seventh day hemoglobin measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Hemoglobin measurement results (g/dL)

  Fourteenth day hemoglobin measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Hemoglobin measurement results (g/dL)

  Twenty-first day hemoglobin measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Albumın measurement results (g/dL)

  Day one albumın measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Albumın measurement results (g/dL)

  Seventh day albumın measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Albumın measurement results (g/dL)

  Fourteenth day albumın measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Albumın measurement results (g/dL)

  Twenty-first day albumın measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Pre-albumin measurement results (g/dL)

  Day one pre-albumin measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Pre-albumin measurement results (g/dL)

  Seventh day pre-albumin measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Pre-albumin measurement results (g/dL)

  Fourteenth day pre-albumin measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Pre-albumin measurement results (g/dL)

  Twenty-first day pre-albumın measurement results (g/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Glucose measurement results (mg/dL)

  Day one glucose measurement results (mg/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Glucose measurement results (mg/dL)

  Fourth day glucose measurement results (mg/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Glucose measurement results (mg/dL)

  Seventh day glucose measurement results (mg/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Glucose measurement results (mg/dL)

  Fourteenth day glucose measurement results (mg/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Glucose measurement results (mg/dL)

  Twenty-first day glucose measurement results (mg/dL)

• Patient Measurements (Life Findings, Laboratory Values)

  Leukocyte measurement results (10\^3/uL)

  Day one leukocyte measurement results (10^3/uL)

• Patient Measurements (Life Findings, Laboratory Values)

  Leukocyte measurement results (10\^3/uL)

  Fourth day leukocyte measurement results (10^3/uL)

• Patient Measurements (Life Findings, Laboratory Values)

  Leukocyte measurement results (10\^3/uL)

  Seventh day leukocyte measurement results (10^3/uL)

• Patient Measurements (Life Findings, Laboratory Values)

  Leukocyte measurement results (10\^3/uL)

  Fourteenth day leukocyte measurement results (10^3/uL)

• Patient Measurements (Life Findings, Laboratory Values)

  Leukocyte measurement results (10\^3/uL)

  Twenty-first day leukocyte measurement results (10^3/uL)

• Patient Measurements (Life Findings, Laboratory Values)

  SaO2 measurement results (%)

  Day one SaO2 measurement results (%)

• Patient Measurements (Life Findings, Laboratory Values)

  SaO2 measurement results (%)

  Fourth day SaO2 measurement results (%)

• Patient Measurements (Life Findings, Laboratory Values)

  SaO2 measurement results (%)

  Seventh day SaO2 measurement results (%)

• Patient Measurements (Life Findings, Laboratory Values)

  SaO2 measurement results (%)

  Fourteenth day SaO2 measurement results (%)

• Patient Measurements (Life Findings, Laboratory Values)

  SaO2 measurement results (%)

  Twenty-first day SaO2 measurement results (%)

• Patient Measurements (Life Findings, Laboratory Values)

  Body Temperature measurement results (degrees centigrade)

  Day one body temperature measurement results (degrees centigrade)

• Patient Measurements (Life Findings, Laboratory Values)

  Body Temperature measurement results (degrees centigrade)

  Fourth day body temperature measurement results (degrees centigrade)

• Patient Measurements (Life Findings, Laboratory Values)

  Body Temperature measurement results (degrees centigrade)

  Seventh day body temperature measurement results (degrees centigrade)

• Patient Measurements (Life Findings, Laboratory Values)

  Body Temperature measurement results (degrees centigrade)

  Fourteenth day body temperature measurement results (degrees centigrade)

• Patient Measurements (Life Findings, Laboratory Values)

  Body Temperature measurement results (degrees centigrade)

  Twenty-first day body temperature measurement results (degrees centigrade)

• Patient Measurements (Life Findings, Laboratory Values)

  Respiratory rate measurement results (.../dak)

  Day one respiratory rate measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Respiratory rate measurement results (.../dak)

  Fourth day respiratory rate measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Respiratory rate measurement results (.../dak)

  Seventh day respiratory rate measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Respiratory rate measurement results (.../dak)

  Fourteenth day respiratory rate measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Respiratory rate measurement results (.../dak)

  Twenty-first day respiratory rate measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Pulse measurement results (.../dak)

  Day one pulse measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Pulse measurement results (.../dak)

  Fourth day pulse measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Pulse measurement results (.../dak)

  Seventh day pulse measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Pulse measurement results (.../dak)

  Fourteenth day pulse measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Pulse measurement results (.../dak)

  Twenty-first day pulse measurement results (.../dak)

• Patient Measurements (Life Findings, Laboratory Values)

  Blood Plessure measurement results (mmHg)

  Day one blood plessure measurement results (mmHg)

• Patient Measurements (Life Findings, Laboratory Values)

  Blood Plessure measurement results (mmHg)

  Fourth day blood plessure measurement results (mmHg)

• Patient Measurements (Life Findings, Laboratory Values)

  Blood Plessure measurement results (mmHg)

  Seventh day blood plessure measurement results (mmHg)

• Patient Measurements (Life Findings, Laboratory Values)

  Blood Plessure measurement results (mmHg)

  Fourteenth day blood plessure measurement results (mmHg)

• Patient Measurements (Life Findings, Laboratory Values)

  Blood Plessure measurement results (mmHg)

  Twenty-first day blood plessure measurement results (mmHg)

• 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

• 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

• Pressure Wound Recovery Time(Day)

  Pressure Wound Recovery Time(Day)

  It will be recorded on which day the wound healed within three weeks.

• 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).

• 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.

• Socio-demographic characteristics of the patient

  Socio-demographic characteristics of the patient

  Sociodemographic characteristics of patients will be recorded for up to three weeks.

• 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.

• 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.

• Body Mass İndeks

  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.

• 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.

Study Arms (2)

Experimental:Intervention Arm

EXPERIMENTAL

For the experimental group patients, sponges prepared by impregnating cream containing Aloe Vera and Propolis will be sterilized in the sterilization device. If any contamination occurs in the wound area of the patient (in the presence of feces, discharge), the product is applied to the wound bed after cleaning the wound with 0.9% isotonic sodium chloride washing solution. And the effects of the product on the wound will be monitored. The solution will be applied 2 times a day for the first 10 days. The second 10 days will be applied daily 1x1. Application results will be recorded and wound healing status will be monitored. In order to prevent and maintain pressure injury, the experimental group patients will be given an in-bed position every 2 hours. If there is a deficiency or deterioration in the patient's laboratory findings (hemoglobin, albumin, prealbumin, leukocyte, blood sugar, SaO2, fever, pulse, blood pressure, etc.), necessary treatment and care is performed.

Other: Aloe vera and propolis applied

No Intervention:Control Arm

NO INTERVENTION

In control group patients, if any pollution occurs in the wound area (feces, discharge) in the sterile dressing performed in the morning and evening at 10-22 hours, the wound area will be cleaned with the help of 0.9% isotonic sodium chloride washing solution and the clinical routine application of the pressure injury of the hospital will be carried out according to the physician's order. In patients in the control group, the results of the application will be recorded and wound healing status will be observed. An in-bed position will be given every 2 hours for the prevention and care of pressure injury patients of the control group patients. If there is a deficiency or deterioration in the patient's laboratory findings (hemoglobin, albumin, prealbumin, leukocyte, blood sugar, SaO2, fever, pulse, blood pressure and other), the necessary treatment and care will be performed.

Interventions

Aloe vera and propolis applied OTHER

Suitable of sterile pads containing aloe vera and propolis to the area with pressure sores

Experimental:Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (4)

Haydarpasa Numune Training and Research Hospital

Üsküdar, Istanbul, 34067, Turkey (Türkiye)

Location

Haydarpasa Numune Training and Research Hospital

Istanbul, 34067, Turkey (Türkiye)

Location

Bahcelievler State Hospital

Istanbul, 34186, Turkey (Türkiye)

Location

Medipol Üniversity

Istanbul, 34810, Turkey (Türkiye)

Location

Related 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.

  PMID: 27840496 BACKGROUND

• Pereira RF, Bartolo PJ. Traditional Therapies for Skin Wound Healing. Adv Wound Care (New Rochelle). 2016 May 1;5(5):208-229. doi: 10.1089/wound.2013.0506.

  PMID: 27134765 BACKGROUND

• Khorasani G, Ahmadi A, Hosseinimehr SJ, 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.

  PMID: 25881055 BACKGROUND

• 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.

  PMID: 30248422 BACKGROUND

• Medellin-Luna MF, Castaneda-Delgado JE, Martinez-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.

  PMID: 30942656 BACKGROUND

Related Links

• 2
• 5

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgery Specialist Nurse

Model Details: The research 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.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: June 28, 2021
• Study Start: March 11, 2021
• Primary Completion: March 11, 2022
• Study Completion: June 11, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)