Pressure UlcerNCT04942470
Effect of Aloe Vera and Propolis on Wound Healing in Pressure Injuries
A study testing Aloe vera and propolis applied in people with Pressure Ulcer, run by Haydarpasa Numune Training and Research Hospital at 4 sites in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Aloe vera and propolis applied
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 11 Mar 2021to 11 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Haydarpasa Numune Training and Research Hospital
Istanbul, 34067
Bahcelievler State Hospital
Istanbul, 34186
Medipol Üniversity
Istanbul, 34810
Haydarpasa Numune Training and Research Hospital
Üsküdar, Istanbul, 34067
About this study
Official title: Phd Candidate/Specialist Surgery Nurse
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.
Read the detailed 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.
- Conditions
- Pressure Ulcer
- Being tested
- Aloe vera and propolis applied
- Keywords
- Aloe Vera, Propolis, Pressure ulcer prevention, Nursing care, Treatment
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe vera and propolis appliedOther
Suitable of sterile pads containing aloe vera and propolis to the area with pressure sores
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Measured: Day one scores
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Measured: Fourth day scores
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Measured: Seventh day scores
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Measured: Fourteenth day scores
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Measured: Twenty-first day scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Measured: Day one scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Measured: Fourth day scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Measured: Seventh day scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Measured: Fourteenth day scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Measured: Twenty-first day scores
Patient Measurements (Life Findings, Laboratory Values)
Hemoglobin measurement results (g/dL)
Measured: Day one hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Hemoglobin measurement results (g/dL)
Measured: Fourth day hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Hemoglobin measurement results (g/dL)
Measured: Seventh day hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Hemoglobin measurement results (g/dL)
Measured: Fourteenth day hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Hemoglobin measurement results (g/dL)
Measured: Twenty-first day hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Albumın measurement results (g/dL)
Measured: Day one albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Albumın measurement results (g/dL)
Measured: Seventh day albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Albumın measurement results (g/dL)
Measured: Fourteenth day albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Albumın measurement results (g/dL)
Measured: Twenty-first day albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Pre-albumin measurement results (g/dL)
Measured: Day one pre-albumin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Pre-albumin measurement results (g/dL)
Measured: Seventh day pre-albumin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Pre-albumin measurement results (g/dL)
Measured: Fourteenth day pre-albumin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Pre-albumin measurement results (g/dL)
Measured: Twenty-first day pre-albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Glucose measurement results (mg/dL)
Measured: Day one glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Glucose measurement results (mg/dL)
Measured: Fourth day glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Glucose measurement results (mg/dL)
Measured: Seventh day glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Glucose measurement results (mg/dL)
Measured: Fourteenth day glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Glucose measurement results (mg/dL)
Measured: Twenty-first day glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Leukocyte measurement results (10^3/uL)
Measured: Day one leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Leukocyte measurement results (10^3/uL)
Measured: Fourth day leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Leukocyte measurement results (10^3/uL)
Measured: Seventh day leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Leukocyte measurement results (10^3/uL)
Measured: Fourteenth day leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Leukocyte measurement results (10^3/uL)
Measured: Twenty-first day leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
SaO2 measurement results (%)
Measured: Day one SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
SaO2 measurement results (%)
Measured: Fourth day SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
SaO2 measurement results (%)
Measured: Seventh day SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
SaO2 measurement results (%)
Measured: Fourteenth day SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
SaO2 measurement results (%)
Measured: Twenty-first day SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
Body Temperature measurement results (degrees centigrade)
Measured: Day one body temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Body Temperature measurement results (degrees centigrade)
Measured: Fourth day body temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Body Temperature measurement results (degrees centigrade)
Measured: Seventh day body temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Body Temperature measurement results (degrees centigrade)
Measured: Fourteenth day body temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Body Temperature measurement results (degrees centigrade)
Measured: Twenty-first day body temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Respiratory rate measurement results (.../dak)
Measured: Day one respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Respiratory rate measurement results (.../dak)
Measured: Fourth day respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Respiratory rate measurement results (.../dak)
Measured: Seventh day respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Respiratory rate measurement results (.../dak)
Measured: Fourteenth day respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Respiratory rate measurement results (.../dak)
Measured: Twenty-first day respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Pulse measurement results (.../dak)
Measured: Day one pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Pulse measurement results (.../dak)
Measured: Fourth day pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Pulse measurement results (.../dak)
Measured: Seventh day pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Pulse measurement results (.../dak)
Measured: Fourteenth day pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Pulse measurement results (.../dak)
Measured: Twenty-first day pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Blood Plessure measurement results (mmHg)
Measured: Day one blood plessure measurement results (mmHg)
Patient Measurements (Life Findings, Laboratory Values)
Blood Plessure measurement results (mmHg)
Measured: Fourth day blood plessure measurement results (mmHg)
Patient Measurements (Life Findings, Laboratory Values)
Blood Plessure measurement results (mmHg)
Measured: Seventh day blood plessure measurement results (mmHg)
Patient Measurements (Life Findings, Laboratory Values)
Blood Plessure measurement results (mmHg)
Measured: Fourteenth day blood plessure measurement results (mmHg)
Patient Measurements (Life Findings, Laboratory Values)
Blood Plessure measurement results (mmHg)
Measured: 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
Measured: 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
Measured: Score change results between day one and day twenty
Pressure Wound Recovery Time(Day)
Pressure Wound Recovery Time(Day)
Measured: 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.
Measured: 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.
Measured: Culture results for three weeks will be recorded.
Socio-demographic characteristics of the patient
Socio-demographic characteristics of the patient
Measured: Sociodemographic characteristics of patients will be recorded for up to three weeks.
Patient health history
Patient health history
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start11 Mar 2021
- Primary completion11 Mar 2022
- Study completion11 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Özgül Aydemir, PHD Candidate, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942470
- Sponsor's protocol ID
- OAydemir1673348861.
- Other IDs
- PHD Candidate
- Status last verified
- Aug 2022
- First submitted
- 21 Apr 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27840496Pereira 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.
PubMed 27134765Khorasani 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.
PubMed 25881055Singh 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.
PubMed 30248422Medellin-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.
PubMed 30942656
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phd Candidate/Specialist Surgery Nurse
- ClinicalTrials.gov ID
- NCT04942470
- Acronym / sponsor ID
- OAydemir1673348861.
- Conditions
- Pressure Ulcer
- Keywords
- Aloe Vera, Propolis, Pressure ulcer prevention, Nursing care, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental:Intervention Arm | Experimental | Other: Aloe vera and propolis appliedFor 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aloe vera and propolis appliedSuitable of sterile pads containing aloe vera and propolis to the area with pressure sores | Other | Experimental:Intervention Arm |
Primary outcome
Braden Pressure Injury Risk Scale Assessment
Time frame: Day one scores
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Time frame: Fourth day scores
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Time frame: Seventh day scores
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Time frame: Fourteenth day scores
Braden Pressure Injury Risk Scale Assessment
Braden Pressure Injury Risk Scale Assessment
Time frame: Twenty-first day scores
Braden Pressure Injury Risk Scale Assessment
Bates-Jensen Wound Assessment Tool Scores
Time frame: Day one scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Time frame: Fourth day scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Time frame: Seventh day scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Time frame: Fourteenth day scores
Bates-Jensen Wound Assessment Tool Scores
Bates-Jensen Wound Assessment Tool Scores
Time frame: Twenty-first day scores
Bates-Jensen Wound Assessment Tool Scores
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one hemoglobin measurement results (g/dL)
Hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourth day hemoglobin measurement results (g/dL)
Hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day hemoglobin measurement results (g/dL)
Hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day hemoglobin measurement results (g/dL)
Hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day hemoglobin measurement results (g/dL)
Hemoglobin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one albumın measurement results (g/dL)
Albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day albumın measurement results (g/dL)
Albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day albumın measurement results (g/dL)
Albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day albumın measurement results (g/dL)
Albumın measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one pre-albumin measurement results (g/dL)
Pre-albumin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day pre-albumin measurement results (g/dL)
Pre-albumin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day pre-albumin measurement results (g/dL)
Pre-albumin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day pre-albumın measurement results (g/dL)
Pre-albumin measurement results (g/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one glucose measurement results (mg/dL)
Glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourth day glucose measurement results (mg/dL)
Glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day glucose measurement results (mg/dL)
Glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day glucose measurement results (mg/dL)
Glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day glucose measurement results (mg/dL)
Glucose measurement results (mg/dL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one leukocyte measurement results (10^3/uL)
Leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourth day leukocyte measurement results (10^3/uL)
Leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day leukocyte measurement results (10^3/uL)
Leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day leukocyte measurement results (10^3/uL)
Leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day leukocyte measurement results (10^3/uL)
Leukocyte measurement results (10^3/uL)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one SaO2 measurement results (%)
SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourth day SaO2 measurement results (%)
SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day SaO2 measurement results (%)
SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day SaO2 measurement results (%)
SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day SaO2 measurement results (%)
SaO2 measurement results (%)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one body temperature measurement results (degrees centigrade)
Body Temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourth day body temperature measurement results (degrees centigrade)
Body Temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day body temperature measurement results (degrees centigrade)
Body Temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day body temperature measurement results (degrees centigrade)
Body Temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day body temperature measurement results (degrees centigrade)
Body Temperature measurement results (degrees centigrade)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one respiratory rate measurement results (.../dak)
Respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourth day respiratory rate measurement results (.../dak)
Respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day respiratory rate measurement results (.../dak)
Respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day respiratory rate measurement results (.../dak)
Respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day respiratory rate measurement results (.../dak)
Respiratory rate measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one pulse measurement results (.../dak)
Pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourth day pulse measurement results (.../dak)
Pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day pulse measurement results (.../dak)
Pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day pulse measurement results (.../dak)
Pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day pulse measurement results (.../dak)
Pulse measurement results (.../dak)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Day one blood plessure measurement results (mmHg)
Blood Plessure measurement results (mmHg)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourth day blood plessure measurement results (mmHg)
Blood Plessure measurement results (mmHg)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Seventh day blood plessure measurement results (mmHg)
Blood Plessure measurement results (mmHg)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Fourteenth day blood plessure measurement results (mmHg)
Blood Plessure measurement results (mmHg)
Patient Measurements (Life Findings, Laboratory Values)
Time frame: Twenty-first day blood plessure measurement results (mmHg)
Blood Plessure measurement results (mmHg)
Aloe Vera and Propolis Applied Experimental Group and Control Group, Bates-Jensen Wound Assessment Tool Scores
Time frame: Score change results between day one and day twenty
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, Braden Pressure Injury Risk Scale Assessment Scores
Time frame: 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
Pressure Wound Recovery Time(Day)
Time frame: It will be recorded on which day the wound healed within three weeks.
Pressure Wound Recovery Time(Day)
The date the wound culture was taken
Time frame: For up to three weeks, deep tissue wound culture results will be recorded as (day/month/year).
It will be recorded as the date (day / month / year) of the wound culture.
Wound culture results
Time frame: Culture results for three weeks will be recorded.
The infectious agent growing in the wound culture (Deep tissue culture) will be recorded.
Socio-demographic characteristics of the patient
Time frame: Sociodemographic characteristics of patients will be recorded for up to three weeks.
Socio-demographic characteristics of the patient
Patient health history
Time frame: This outcome measure includes the patient's health history of existing chronic diseases and any co-morbidities developed during the three-week study period.
Patient health history
Height, Weight
Time frame: 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.
Height .... cm or Weight .... kg
Body Mass İndeks
Time frame: 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.
kg/m2
Current disease information and medications used
Time frame: 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.
Current disease information and medications used
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 27840496Avijgan 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.
- Background: PubMed 27134765Pereira 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.
- Background: PubMed 25881055Khorasani 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.
- Background: PubMed 30248422Singh 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.
- Background: PubMed 30942656Medellin-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.
- 2Link provided by the sponsor.
- 5Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aloe vera and propolis applied in people with Pressure Ulcer, run by Haydarpasa Numune Training and Research Hospital at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Braden Pressure Injury Risk Scale Assessment (time frame: Day one scores). The study lists 68 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942470, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.