Effect of Propolis Application on Burn Healing

Izmir Katip Celebi University

Status: Completed

Conditions: Burns; Burn Wound

Treatments: Biological: burn wound dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT04277182

2019-048

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 8 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 6 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

It will be accepted as the control group and 4 experimental burn wounds will be created on the back of the rats in the group and no treatment will be given.

Treatment:

Biological: burn wound dressing

1% Silver Sulfadiazine

Active Comparator group

Description:

4 experimental burn wounds will be created on the back of the rats in the group and dressing with 1% Silver Sulfadiazine will be done on the back of the rats every day for 21 days.

Treatment:

Biological: burn wound dressing

%0.2 Nitrafurozon

Active Comparator group

Description:

4 experimental burn wounds will be created on the back of the rats in the group and dressing with %0.2 Nitrafurozon will be done on the back of the rats every day for 21 days.

Treatment:

Biological: burn wound dressing

10% Propolis

Experimental group

Description:

4 experimental burn wounds will be created on the back of the rats in the group and dressing with 10% Propolis will be done on the back of the rats every day for 21 days.

Treatment:

Biological: burn wound dressing

15% Propolis

Experimental group

Description:

4 experimental burn wounds will be created on the back of the rats in the group and dressing with 15% Propolis will be done on the back of the rats every day for 21 days.

Treatment:

Biological: burn wound dressing

Propolis vehicle

Active Comparator group

Description:

4 experimental burn wounds will be created on the back of the rats in the group and dressing with Propolis vehicle will be done on the back of the rats every day for 21 days.

Treatment:

Biological: burn wound dressing