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IRCT20210524051384N2 IRCT 2021-10-14 Rasht University of Medical Sciences The effect of using medical honey on the attachment of skin grafts The study of using medical honey compared to stapler(Advan disposable skin stapler) for skin graft fixation in burn wounds 2021-11-22 anticipated 80 Complete https://irct.ir/trial/59104 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the treatment between the groups, 4 permutation blocks method will be used. Group A is the intervention group and group B is the control group, and data randomization was performed with SAS software version 9. N/A Burns. Intervention 1: Intervention group: Using honey instead of stapler to attach skin grafts.The medical honey used in this study is(Madi Hani) honey gel available in the market which is free from all the harms of ordinary honey to preserve all the properties of honey, including enzymes and diastases. Honey is refined at temperatures below 50 degrees. This honey has a low pH and high osmolarity with high antibacterial properties against the spectrum. A wide range of resistant strains along with maintaining the ideal moisture of the wound environment plays an effective role in healing. Patients with second and third deep grad of burn wounds require a graft, with burns less than 40% that are done in a single step that requires an autograft skin graft from the patient after the necessary and sufficient explanations about the study and the procedure for patients by an expert and physician and obtaining informed consent from 80 patients who are candidates for skin graft surgery using honey, which is removed from the patient with a skin dermatome device and placed in the appropriate area. Intervention 2: Control group: the use of stapler in attaching skin grafts. A stapler will be used to attach the skin graft to the underlying tissue. Using Advan disposable skin stapler which is disposable and is provided by Farab Surgeon Company, which is made and sterilized by the factory and is disposed of after use. Patients with second and third deep grad of burn wounds require a graft, with burns less than 40% that are done in a single step that requires an autograft skin graft from the patient after the necessary and sufficient explanations about the study and the procedure for patients by an expert and physician and obtaining informed consent from 80 patients who are candidates for skin graft surgery using honey, which is removed from the patient with a skin dermatome device and placed in the appropriate area. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet - The release schedule is still unknown
public Dr.mohammadreza Mobayen
Velayat Hospital, Namjo Street
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 maziar.mobayen@gmail.com Rasht University of Medical Sciences scientific Dr.Mohammadreza Mobayen
Velayat Hospital, Namjo Street
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) All patients with deep grade 2 and 3 of burn wounds who need a graft and burns with less than 40% which are performed in one- step. 20 years no limit Both Grafts that are performed late and in several stages and people with debilitating diseases and defected immune system, diabetes and Cortone users and burns injuries on the head, face, neck ,joints and allergies to honey and its products. Z94.5 Skin transplant status Treatment - Drugs Treatment - Devices Intervention group: Using honey instead of stapler to attach skin grafts.The medical honey used in this study is(Madi Hani) honey gel available in the market which is free from all the harms of ordinary honey to preserve all the properties of honey, including enzymes and diastases. Honey is refined at temperatures below 50 degrees. This honey has a low pH and high osmolarity with high antibacterial properties against the spectrum. A wide range of resistant strains along with maintaining the ideal moisture of the wound environment plays an effective role in healing. Patients with second and third deep grad of burn wounds require a graft, with burns less than 40% that are done in a single step that requires an autograft skin graft from the patient after the necessary and sufficient explanations about the study and the procedure for patients by an expert and physician and obtaining informed consent from 80 patients who are candidates for skin graft surgery using honey, which is removed from the patient with a skin dermatome device and placed in the appropriate area. Control group: the use of stapler in attaching skin grafts. A stapler will be used to attach the skin graft to the underlying tissue. Using Advan disposable skin stapler which is disposable and is provided by Farab Surgeon Company, which is made and sterilized by the factory and is disposed of after use. Patients with second and third deep grad of burn wounds require a graft, with burns less than 40% that are done in a single step that requires an autograft skin graft from the patient after the necessary and sufficient explanations about the study and the procedure for patients by an expert and physician and obtaining informed consent from 80 patients who are candidates for skin graft surgery using honey, which is removed from the patient with a skin dermatome device and placed in the appropriate area Efficiency of honey in attaching skin grafts. Timepoint: Duration of hospitalization. Method of measurement: By observing skin graft area and experienced burn specialist's opinion. Evaluating the degree of displacement of grafted skin. Timepoint: On fifth, seventh and fourteenth days after surgery. Method of measurement: Based on millimeters. Infection after skin graft surgery. Timepoint: On seventh, fourteenth and one month after surgery. Method of measurement: Based on culture and Antibiogram. Hematoma. Timepoint: On fifth, seventh and fourteenth days after surgery. Method of measurement: By observing the accumulation of blood outside the vessels around the skin graft. The amount of pain. Timepoint: At 3, 6, 12 and 24 hours and by the third day after surgery. Method of measurement: Using the VAS criteria. Itching. Timepoint: At 3, 6, 12 and 24 hours and by the third day after surgery. Method of measurement: Through the 5-D criterion based on the lenght, severity, recovery and disability degree caused by itching. Edema. Timepoint: On fifth, seventh and fourteenth days after surgery. Method of measurement: By observing the abnormal accumulation of interstitial fluid water under the skin graft and observing by professionals. Shrinkage of the skin graft. Timepoint: On fifth, seventh and fourteenth days after surgery. Method of measurement: Based on millimeters (length and width). Follow-up of transplantation. Timepoint: On fifth, seventh and fourteenth days after surgery. Method of measurement: Based on discoloration of transplanted skin and photography and observing by burn specialist's opinion. Duration of hospitalization. Timepoint: Duration of patients' hospitalization. Method of measurement: Day. Vice-Chancellor for Research, Guilan University of Medical Sciences Approved 2021-09-29 Research Ethic Committees of Guilan University of Medical science Guilan University of Medical science Rasht Guilan Iran (Islamic Republic of)