Study desgine
skin blisters, fracture, Hemorrhagic, fractures, blisters, Fractures
PAD, SENSITIVITY
This is a clinical trial study conducted according to the guidelines of the Ethical Committee of Isfahan University of Medical Sciences (Ethics code: IR.MUI.MED.REC.1401.025, Iranian Registry of Clinical Trials (IRCT) code: IRCT20221207056744N1). Eligible patients attending the Orthopedic Clinic of Isfahan Research Center, Isfahan, Iran, between 2021, and 2022, were randomly assigned. The date of sending the article to the research vice-chancellor of the Esfahan university of medical science was 15/10/2021, Faculty approval date was 23/02/2022, the date of obtaining the ethics code was 17/04/2022, University approval date was 22/05/2022, and registration of our trial protocol under the scientific mentioned name has been approved in Iranian Registry of Clinical Trials at 08/01/2023. our registration reference is IRCT20221207056744N1.This is a double-blinded pioneering randomized trial that compares the effectiveness of two dressings containing silver (Ag coat) and Gaz Vaseline among patients with skin blisters due to bone fractures who were randomly selected from patients referred to the Kashani Medical Training Center. All fractures were closed in the lower extremity. Fractures are all simple in both groups. The communitive fractures are excluded at the beginning of the research. After the selection, the participants were randomly assigned to the experimental and control groups using lottery cards, so that the results of their allocation to the groups were accessible only after the completion of the initial evaluations by the research staff. As a single-blinded study Participants were blinded to grouping and assignments.The inclusion criteria included all patients with blisters due to bone fracture, aged between 18–65, and Consent to participate in the study.The exclusion criteria included Sensitivity to silver, Amputation indication, patients who did not agree to participate in the study, and those who did not participate in the study until the end and did not come for follow-up sessions.The patients were fully informed about the risks, advantages, and trial process. The informed consent was taken from those patients who met the following requirements. They had been diagnosed after the first admission to the Kashani Hospital. They were aged between 18 and 65 years with non-healing blisters that had been created due to bone fracture. All blisters were located on the leg and foot; finally, the patients read, comprehended, and signed the informed consent specific to the study.Neither the therapist and analyst nor the patient know about the treatment and control group. A third person who did not know about the research and the type of treatments simply randomized the patients into 2 groups; in group A, they were treated with Agi Coat dressing and in group B, they were treated with Gaz Vaseline for coating the blister. Agi coat dressing, which was used in this study, was produced by Emad Pharmaceutical Company, Razi industrial zone, Isfahan, Iran.Code and technical specifications of AGICOAT medical dressing pad:
This dressing is a single-layer dressing with a coating of silver nanocrystals, which are coated by the chemical reduction method, silver on a network of nylon fibers with very high flexibility. This layer exerts its antimicrobial and anti-inflammatory effects by slowly releasing silver ions.The blisters were also divided into Hemorrhagic and non-hemorrhagic groups.