Effect of Propolis Application on Burn Healing
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StatusNot yet recruiting
Sponsors
Izmir Katip Celebi University
CLINICAL TRIAL: NCT04277182
BioSeek: nct04277182
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 02/16/2020 |
| Estimated Enrollment Submitted: | 02/17/2020 |
| First Posted: | 02/19/2020 |
| Last Update Submitted: | 06/29/2020 |
| Last Update Posted: | 07/01/2020 |
| Actual Study Start Date: | 08/31/2020 |
| Estimated Primary Completion Date: | 09/30/2020 |
| Estimated Study Completion Date: | 12/31/2020 |
Condition or disease
Burns
Burn Wound
Intervention/treatment
Biological: burn wound dressing
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Control group 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. | |
| Active Comparator: 1% Silver Sulfadiazine 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. | |
| Active Comparator: %0.2 Nitrafurozon 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. | |
| Experimental: 10% Propolis 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. | |
| Experimental: 15% Propolis 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. | |
| Active Comparator: Propolis vehicle 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. |
Eligibility Criteria
| Ages Eligible for Study | 8 Weeks To 8 Weeks |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. tumour necrosis factor-alpha, [3rd days]
will be studied for the evaluation of acute phase reactants.
2. tumour necrosis factor-alpha, [7th days]
will be studied for the evaluation of acute phase reactants.
3. interleukin-1β [3rd days]
will be studied for the evaluation of acute phase reactants.
4. interleukin-1β [7th days]
will be studied for the evaluation of acute phase reactants.
5. superoxide dismutase [3rd days]
will be studied for the evaluation of oxidative stress
6. superoxide dismutase [7th days]
will be studied for the evaluation of oxidative stress
7. malondialdehyde [3rd days]
will be studied for the evaluation of oxidative stress
8. malondialdehyde [7th days]
will be studied for the evaluation of oxidative stress
9. myeloperoxidase [3rd days]
will be studied for the evaluation of oxidative stress
10. myeloperoxidase [7th days]
will be studied for the evaluation of oxidative stress
11. hydroxyproline [14th days]
will be studied for the evaluation of collagen
12. hydroxyproline [21st days]
will be studied for the evaluation of collagen
13. Masson trichrome [14th days]
will be studied for the evaluation of fibrosis
14. Masson trichrome [21st days]
will be studied for the evaluation of fibrosis
Secondary Outcome Measures
1. wound size [21 days]
photos will be taken every day to determine the wound size
2. bulla [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
3. erythema [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.
4. edema [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
5. inflammatory cell infiltration [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
6. necrosis [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
7. ulceration [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
8. angiogenesis [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
9. neovascularization [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Neovascularization will be considered as present or absent.
10. fibroblast proliferation [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
11. epithelization [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
12. umber of hair follicles [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Umber will be considered as present or absent.
13. damage of skin attachments [3rd, 7th, 14th and 21st days]
examination of the skin at the light microscopic level. Damage will be considered as present or absent.
