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IRCT20240518061832N1 IRCT 2024-10-17 Shahid Beheshti University of Medical Sciences Investigating the effectiveness of intranasal PRF treatment compared to standard treatment on mucosal healing at the cautery site during rhinosinusitis endoscopic surgery in chronic rhinosinusitis patients PRF Investigating the effectiveness of intranasal PRF treatment compared to standard treatment on mucosal healing at the cautery site during rhinosinusitis endoscopic surgery in chronic rhinosinusitis patients referred to Taleghani Hospital during 1403-1405 2024-10-06 anticipated 61 Complete https://irct.ir/trial/79311 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For simple randomization, the number table of Rand company's program is used, and a plan is given for intervention in each of the donor nasal cavities by the operator, and one of the cavities is randomly selected as the intervention group, and fibrin rich in platelets is included in it. The hole is placed. Also, the other hole is determined as a sample and control group. All this information is recorded by the project manager, and in order not to affect the surgical procedure, the surgeon is not informed until the end of the operation. N/A Chronic sinusitis after endoscopic surgery. Intervention 1: Intervention group: In this study, all adult patients over 18 years of age suffering from chronic rhinosinusitis undergoing FESS surgery who referred to Taleghani Hospital from 1403 to 1405 will be examined. In this study, patients for whom electrocautery is used in two nasal cavities during FESS surgery, platelet-rich fibrin (PRF) is prepared using the patient's own venous blood, and randomly placed in one of the nasal cavities at the cautery site. Intervention 2: Control group: After one of the patient's nasal cavities was randomly selected for intervention. The other cavity of the nose is repaired in a standard way, and this cavity is considered as the control group. Then both cavities under the endoscopic guide are homeostasised and packed in the same way. With this method, the control group and the intervention are performed on one patient, which creates a better matching for this plan. Yes - There is a plan to make this available What will be shared: Patient information remains confidential, but results are shared with privacy and data protection When: always To whom: everyone Conditions: All items Where to obtain: Email of the responsible person How to obtain: Contact by phone or email Comments:
public vahid ghasem amooeian
Tehran Province, Tajrish، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2243 9770 vahidvm2m@gmail.com Shahid Beheshti University of Medical Sciences scientific matin ghazi zadeh
2 SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1983969411 +98 21 23871 vahidvm2m@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Bilateral chronic rhinosinusitis with nasal polyps A difference in scores of two or less LUND MACKY SCORE between both nasal cavities Age between 18 and 60 years 18 years 60 years Both Patients with unilateral nasal polyps antrochoanal polyp Chronic rhinosinusitis without polyps History of nose or sinus surgery Immunity deficiency Treatment - Surgery Treatment - Surgery Intervention group: In this study, all adult patients over 18 years of age suffering from chronic rhinosinusitis undergoing FESS surgery who referred to Taleghani Hospital from 1403 to 1405 will be examined. In this study, patients for whom electrocautery is used in two nasal cavities during FESS surgery, platelet-rich fibrin (PRF) is prepared using the patient's own venous blood, and randomly placed in one of the nasal cavities at the cautery site. Control group: After one of the patient's nasal cavities was randomly selected for intervention. The other cavity of the nose is repaired in a standard way, and this cavity is considered as the control group. Then both cavities under the endoscopic guide are homeostasised and packed in the same way. With this method, the control group and the intervention are performed on one patient, which creates a better matching for this plan. Determining and comparing the effectiveness of intranasal platelet-rich fibrin (PRF) treatment with standard treatment on wound healing at the cautery site during FESS surgery in chronic sinusitis patients. Timepoint: Patients 3 days after surgery and after removing tampons if any and two weeks after surgery and one month after surgery and three months after surgery in terms of shortness of breath and bleeding and endoscopic findings in terms of adhesion and wound healing and site Wounds and cautery are checked. Method of measurement: Accordingly, the following were scored by endoscopic assessment: Adhesion (0 = none, 1 = adhesion not affecting sinus drainage, 2 = moderate adhesion affecting sinus drainage, 3 = complete adhesion between the middle and lateral prongs of the nasal wall (bleeding) 0 = none; 1 = minimal, confined to nasal cavity; 3 = severe, need for cauterization (0 = minimal, 2 = moderate, 3 = severe) (0) = no infection, 1 = mild purulent mucous discharge, 2 = moderate purulent mucous discharge, 3 = severe purulent mucous discharge) granulation (0 = none, 1 = minimal, 2 = moderate, 3 = severe) also from patient questionnaire NOSE and history are taken before and after surgery and during the follow-up period. Finally, all the information is collected and then the statistical analysis of the data is done. Shahid Beheshti University of Medical Sciences Approved 2024-09-18 Shahid Beheshti University of Medical Sciences Tehran Province, Tajrish، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave Tehran Tehran Iran (Islamic Republic of)