Clinical trial NCT04277182: Effect of Propolis Application on Burn Healing
Official title: Effect of Topical Turkish Propolis Application on Burn Healing in Experimental Burn Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Burn Wound
Keywords: Burn
Burn wound
Propolis
Wound healing
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * 1st. group: It will be considered as a control group and rats will not be treated.
* 2nd. group: Vehicle group, Propolis vehicle will be applied to rats for 21 days.
* 3rd. group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.
* 4th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.
* 5th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.
* 6th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: wound size
timeFrame: 21 days
measure: bulla
timeFrame: 3rd day of the research
measure: bulla
timeFrame: 7th day of the research
measure: bulla
timeFrame: 14th day of the research
measure: bulla
timeFrame: 21st day day of the research
measure: edema
timeFrame: 3rd day of the research
measure: edema
timeFrame: 7th day of the research
measure: edema
timeFrame: 14th day of the research
measure: edema
timeFrame: 21st day of the research
measure: inflammatory cell infiltration
timeFrame: 3rd day of the research
measure: inflammatory cell infiltration
timeFrame: 7th day of the research
measure: inflammatory cell infiltration
timeFrame: 14th day of the research
measure: inflammatory cell infiltration
timeFrame: 21st day of the research
measure: necrosis
timeFrame: 3rd day of the research
measure: necrosis
timeFrame: 7th day of the research
measure: necrosis
timeFrame: 14th day of the research
measure: necrosis
timeFrame: 21st day of the research
measure: ulceration
timeFrame: 3rd day of the research
measure: ulceration
timeFrame: 7th day of the research
measure: ulceration
timeFrame: 14th day of the research
measure: ulceration
timeFrame: 21st day of the research
measure: angiogenesis
timeFrame: 3rd day of the research
measure: angiogenesis
timeFrame: 7th day of the research
measure: angiogenesis
timeFrame: 14th day of the research
measure: angiogenesis
timeFrame: 21st day of the research
measure: fibroblast proliferation
timeFrame: 3rd day of the research
measure: fibroblast proliferation
timeFrame: 7th day of the research
measure: fibroblast proliferation
timeFrame: 14th day of the research
measure: fibroblast proliferation
timeFrame: 21st day of the research
measure: epithelization
timeFrame: 3rd day of the research
measure: epithelization
timeFrame: 7th day of the research
measure: epithelization
timeFrame: 14th day of the research
measure: epithelization
timeFrame: 21st day of the research
measure: collagenization
timeFrame: 3rd day of the research
measure: collagenization
timeFrame: 7th day of the research
measure: collagenization
timeFrame: 14th day of the research
measure: collagenization
timeFrame: 21st day of the research
measure: microorganism colonization
timeFrame: 3rd day of the research
measure: microorganism colonization
timeFrame: 7th day of the research
measure: microorganism colonization
timeFrame: 14th day of the research
measure: microorganism colonization
timeFrame: 21st day of the research
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇zmi̇r
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University
name: Figen Yardımcı
role: STUDY_DIRECTOR
References: