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NCT Number: NCT04942470

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

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.

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydarpasa Numune Training and Research Hospital, Üsküdar, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aloe vera and propolis applied

Other

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

Primary outcomes

  1. Braden Pressure Injury Risk Scale Assessment

    Time frame: Day one scores

    Braden Pressure Injury Risk Scale Assessment

  2. Braden Pressure Injury Risk Scale Assessment

    Time frame: Fourth day scores

    Braden Pressure Injury Risk Scale Assessment

  3. Braden Pressure Injury Risk Scale Assessment

    Time frame: Seventh day scores

    Braden Pressure Injury Risk Scale Assessment

  4. Braden Pressure Injury Risk Scale Assessment

    Time frame: Fourteenth day scores

    Braden Pressure Injury Risk Scale Assessment

  5. Braden Pressure Injury Risk Scale Assessment

    Time frame: Twenty-first day scores

    Braden Pressure Injury Risk Scale Assessment

  6. Bates-Jensen Wound Assessment Tool Scores

    Time frame: Day one scores

    Bates-Jensen Wound Assessment Tool Scores

  7. Bates-Jensen Wound Assessment Tool Scores

    Time frame: Fourth day scores

    Bates-Jensen Wound Assessment Tool Scores

  8. Bates-Jensen Wound Assessment Tool Scores

    Time frame: Seventh day scores

    Bates-Jensen Wound Assessment Tool Scores

  9. Bates-Jensen Wound Assessment Tool Scores

    Time frame: Fourteenth day scores

    Bates-Jensen Wound Assessment Tool Scores

  10. Bates-Jensen Wound Assessment Tool Scores

    Time frame: Twenty-first day scores

    Bates-Jensen Wound Assessment Tool Scores

  11. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Day one hemoglobin measurement results (g/dL)

    Hemoglobin measurement results (g/dL)

  12. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourth day hemoglobin measurement results (g/dL)

    Hemoglobin measurement results (g/dL)

  13. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Seventh day hemoglobin measurement results (g/dL)

    Hemoglobin measurement results (g/dL)

  14. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourteenth day hemoglobin measurement results (g/dL)

    Hemoglobin measurement results (g/dL)

  15. Patient Measurements (Life Findings, Laboratory Values)

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

    Hemoglobin measurement results (g/dL)

  16. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Day one albumın measurement results (g/dL)

    Albumın measurement results (g/dL)

  17. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Seventh day albumın measurement results (g/dL)

    Albumın measurement results (g/dL)

  18. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourteenth day albumın measurement results (g/dL)

    Albumın measurement results (g/dL)

  19. Patient Measurements (Life Findings, Laboratory Values)

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

    Albumın measurement results (g/dL)

  20. Patient Measurements (Life Findings, Laboratory Values)

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

    Pre-albumin measurement results (g/dL)

  21. Patient Measurements (Life Findings, Laboratory Values)

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

    Pre-albumin measurement results (g/dL)

  22. Patient Measurements (Life Findings, Laboratory Values)

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

    Pre-albumin measurement results (g/dL)

  23. Patient Measurements (Life Findings, Laboratory Values)

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

    Pre-albumin measurement results (g/dL)

  24. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Day one glucose measurement results (mg/dL)

    Glucose measurement results (mg/dL)

  25. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourth day glucose measurement results (mg/dL)

    Glucose measurement results (mg/dL)

  26. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Seventh day glucose measurement results (mg/dL)

    Glucose measurement results (mg/dL)

  27. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourteenth day glucose measurement results (mg/dL)

    Glucose measurement results (mg/dL)

  28. Patient Measurements (Life Findings, Laboratory Values)

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

    Glucose measurement results (mg/dL)

  29. Patient Measurements (Life Findings, Laboratory Values)

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

    Leukocyte measurement results (10^3/uL)

  30. Patient Measurements (Life Findings, Laboratory Values)

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

    Leukocyte measurement results (10^3/uL)

  31. Patient Measurements (Life Findings, Laboratory Values)

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

    Leukocyte measurement results (10^3/uL)

  32. Patient Measurements (Life Findings, Laboratory Values)

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

    Leukocyte measurement results (10^3/uL)

  33. Patient Measurements (Life Findings, Laboratory Values)

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

    Leukocyte measurement results (10^3/uL)

  34. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Day one SaO2 measurement results (%)

    SaO2 measurement results (%)

  35. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourth day SaO2 measurement results (%)

    SaO2 measurement results (%)

  36. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Seventh day SaO2 measurement results (%)

    SaO2 measurement results (%)

  37. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourteenth day SaO2 measurement results (%)

    SaO2 measurement results (%)

  38. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Twenty-first day SaO2 measurement results (%)

    SaO2 measurement results (%)

  39. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Day one body temperature measurement results (degrees centigrade)

    Body Temperature measurement results (degrees centigrade)

  40. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourth day body temperature measurement results (degrees centigrade)

    Body Temperature measurement results (degrees centigrade)

  41. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Seventh day body temperature measurement results (degrees centigrade)

    Body Temperature measurement results (degrees centigrade)

  42. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourteenth day body temperature measurement results (degrees centigrade)

    Body Temperature measurement results (degrees centigrade)

  43. Patient Measurements (Life Findings, Laboratory Values)

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

    Body Temperature measurement results (degrees centigrade)

  44. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Day one respiratory rate measurement results (.../dak)

    Respiratory rate measurement results (.../dak)

  45. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourth day respiratory rate measurement results (.../dak)

    Respiratory rate measurement results (.../dak)

  46. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Seventh day respiratory rate measurement results (.../dak)

    Respiratory rate measurement results (.../dak)

  47. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourteenth day respiratory rate measurement results (.../dak)

    Respiratory rate measurement results (.../dak)

  48. Patient Measurements (Life Findings, Laboratory Values)

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

    Respiratory rate measurement results (.../dak)

  49. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Day one pulse measurement results (.../dak)

    Pulse measurement results (.../dak)

  50. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourth day pulse measurement results (.../dak)

    Pulse measurement results (.../dak)

  51. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Seventh day pulse measurement results (.../dak)

    Pulse measurement results (.../dak)

  52. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourteenth day pulse measurement results (.../dak)

    Pulse measurement results (.../dak)

  53. Patient Measurements (Life Findings, Laboratory Values)

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

    Pulse measurement results (.../dak)

  54. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Day one blood plessure measurement results (mmHg)

    Blood Plessure measurement results (mmHg)

  55. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourth day blood plessure measurement results (mmHg)

    Blood Plessure measurement results (mmHg)

  56. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Seventh day blood plessure measurement results (mmHg)

    Blood Plessure measurement results (mmHg)

  57. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Fourteenth day blood plessure measurement results (mmHg)

    Blood Plessure measurement results (mmHg)

  58. Patient Measurements (Life Findings, Laboratory Values)

    Time frame: Twenty-first day blood plessure measurement results (mmHg)

    Blood Plessure measurement results (mmHg)

  59. 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

  60. 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

  61. 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)

  62. 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.

  63. 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.

  64. 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

  65. 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

  66. 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

  67. 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

  68. 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

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

Phd Candidate/Specialist Surgery Nurse

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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