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Completed

NCT Number: NCT04277182

Effect of Propolis Application on Burn Healing

This experimental study will be carried out at Ege University Laboratory Animals Application and Research Center to identify the efficacy of 10% propolis and 15% propolis on wound healing in a second-degree superficial burn wound.

In the study, 36 adult (8-12 week old) Wistar-Albino rats with a weight of 200-300 grams will be used in each group. Each group will include 6 rats. Stratified randomization will be used to randomize rats according to their gender and weight. After randomization, a burnt area will be created on the back of the rats and dressings will be made every day.

Following the creation of the burn, biopsy samples will be taken on the 3rd, 7th, 14th and 21st days and at the light microscopic level; bulla, erythema, oedema, burn depth, inflammatory cell infiltration, necrosis, ulceration, angiogenesis, neovascularization, fibroblast proliferation, collagenization, epithelization, fibrosis, the number of hair follicles and damage to the skin attachments.

In the immunohistochemical examination of biopsy samples, samples will be taken for the evaluation of superoxide dismutase, malondialdehyde, myeloperoxidase in the evaluation of the tumour necrosis factor-alpha, interleukin-1β and oxidative stress in the EBB period in order to evaluate the acute phase reactants. Fungal and gram staining will be done in order to determine the pathogen reproduction in biopsy samples taken on the 3rd and 7th day. Masson trichrome in order to detect fibrosis in biopsy samples taken on the 14th and 21st day; Hydroxyproline examination will be examined in order to evaluate collagen formation.

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Key information

Conditions

Burns Burn Wound Wounds and Injuries

Age range

8 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult (8-12 weeks)
  • 200-300 grams
  • Wistar-Albino rat
  • with 4 second-degree superficial contact burn are at its back.

Exclusion criteria

  • the death of the rat in the research process

Treatment and study plan

burn wound dressing

Biological
  • st. group: It will be considered as a control group and rats will not be treated.
  • nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.
  • rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.
  • th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.
  • th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.
  • th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.

Primary outcomes

  1. wound size

    Time frame: 21 days

    photos will be taken every day to determine the wound size

  2. bulla

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Bulla will be considered as present or absent.

  3. bulla

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Bulla will be considered as present or absent.

  4. bulla

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Bulla will be considered as present or absent.

  5. bulla

    Time frame: 21st day day of the research

    examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.

  6. edema

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Edema will be considered as present or absent.

  7. edema

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Edema will be considered as present or absent.

  8. edema

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Edema will be considered as present or absent.

  9. edema

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Edema will be considered as present or absent.

  10. inflammatory cell infiltration

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.

  11. inflammatory cell infiltration

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.

  12. inflammatory cell infiltration

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.

  13. inflammatory cell infiltration

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.

  14. necrosis

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.

  15. necrosis

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.

  16. necrosis

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.

  17. necrosis

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.

  18. ulceration

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.

  19. ulceration

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.

  20. ulceration

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.

  21. ulceration

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.

  22. angiogenesis

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.

  23. angiogenesis

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.

  24. angiogenesis

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.

  25. angiogenesis

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.

  26. fibroblast proliferation

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.

  27. fibroblast proliferation

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.

  28. fibroblast proliferation

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.

  29. fibroblast proliferation

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.

  30. epithelization

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.

  31. epithelization

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.

  32. epithelization

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.

  33. epithelization

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.

  34. collagenization

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.

  35. collagenization

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.

  36. collagenization

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.

  37. collagenization

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.

  38. microorganism colonization

    Time frame: 3rd day of the research

    examination of the skin at the light microscopic level. Colonization will be considered as present or absent.

  39. microorganism colonization

    Time frame: 7th day of the research

    examination of the skin at the light microscopic level. Colonization will be considered as present or absent.

  40. microorganism colonization

    Time frame: 14th day of the research

    examination of the skin at the light microscopic level. Colonization will be considered as present or absent.

  41. microorganism colonization

    Time frame: 21st day of the research

    examination of the skin at the light microscopic level. Colonization will be considered as present or absent.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

Effect of Topical Turkish Propolis Application on Burn Healing in Experimental Burn Model

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2020
Registry last updated
Aug 3, 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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