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IRCT20211121053135N1 IRCT 2022-02-06 Kermanshah University of Medical Sciences Comparison of the skin effects of pretreatment preparation with chlorhexidine solution and povidone-iodine before rhinoplasty: a randomized clinical trial Comparison of the skin effects of pretreatment preparation with chlorhexidine solution and povidone-iodine before rhinoplasty: a randomized clinical trial 2021-12-22 anticipated 42 Complete https://irct.ir/trial/60424 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Random numbers are generated using Excel software by a statistician to do this. Four-digit codes are generated. A four digit code is allocated to each patient and the last digit on the right indicates the patient group. if the number obtained is odd(1,3,5,7,9), the patient is in the chlorhexidine group and if the number is even(0,2,4,6,8), the patient is in the povidone-iodine group Each of the generated codes is kept separately inside the envelope and the receptionist gives one of these envelopes to the patient before entering the operating room. Accordingly, the next patient code is not predictable. Based on the patient's code, the physician determines which treatments to implement, Only the physician who implements the intervention knows the code allocated to the patient, which after evaluating the outcome, based on thepatient's name, the information collected will be related to the assigned codes, Blinding description: Blinding is performed in 2 levels including the patient and outcome assessor . As the irrigation with chlorhexidine and povidone-iodine is done while anesthesia , the patient is uninformed about the kind of intervention. Also the outcome assessor who is the dermatologist is uninformed about the kind of patients intervention. Therefore in this study both the patient and the outcome assessor are uninformed about the kind of patient intervention. 2 Condition 1: Urticaria. Condition 2: Erythema. Condition 3: Acne. Condition 4: Macula. Condition 5: Papula. Condition 6: Plaque. Condition 7: Seborrheic dermatitis. Condition 8: Perioral dermatitis. Condition 9: Allergic contact dermatitis. Condition 10: Itching. Condition 11: Burning. Condition 12: Scabbing. Intervention 1: Intervention group (first): in chlorhexidine group, face prepping before surgery is done by 2% chlorhexidine.one surgeon operate them with open method and with midazolam induction, narcotic(fentanyl), atracurium(laxative) and propofol on the basis of person's per kilogram, and the surgery duration is about 1/5 hour and after that all the patients have tampon for 3 days, in addition to they have splint and mesh for one week on their nose. Intervention 2: Intervention group(second): in povidone-iodine group, face prepping before surgery is done by 10% povidone-iodine. one surgeon operate them with open method and with midazolam induction, narcotic(fentanyl), atracurium(laxative) and propofol on the basis of person's per kilogram, and the surgery duration is about 1/5 hour and after that all the patients have tampon for 3 days, in addition to they have splint and mesh for one week on their nose. 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 there is no more information
public Hoshyar Abbasi
Moayed Ave, Sobhan Building
Kermanshah Iran (Islamic Republic of) 6714738178 +98 83 3729 2254 hoshyar7ab@yahoo.com Kermanshah University of Medical Sciences scientific Hoshyar Abbasi
Moayed Ave, Sobhan Building
Kermanshah Iran (Islamic Republic of) 6714738178 +98 83 3729 2254 hoshyar7ab@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) ASA I or II health status. The patient is ready to take part in the study and sign the testimonial. 18 years no limit Both History of underlying diseases affecting the wound healing process like systemic diseases(diabetes, high blood pressure, gastrointestinal system diseases, kidney disorders, heart and lung diseases) Current consumption of drugs, alcohol, opiums (consumption of any of these substances during the last month) Pregnant women Any allergies or Hypersensitivities to the drugs used in this study L50 B08.3 L70 L21 L71.0 L23 Urticaria Erythema infectiosum [fifth disease] Acne Macula Papula Plaque Seborrheic dermatitis Perioral dermatitis Allergic contact dermatitis Itching Burning Scabbing Prevention Prevention Intervention group (first): in chlorhexidine group, face prepping before surgery is done by 2% chlorhexidine.one surgeon operate them with open method and with midazolam induction, narcotic(fentanyl), atracurium(laxative) and propofol on the basis of person's per kilogram, and the surgery duration is about 1/5 hour and after that all the patients have tampon for 3 days, in addition to they have splint and mesh for one week on their nose. Intervention group(second): in povidone-iodine group, face prepping before surgery is done by 10% povidone-iodine. one surgeon operate them with open method and with midazolam induction, narcotic(fentanyl), atracurium(laxative) and propofol on the basis of person's per kilogram, and the surgery duration is about 1/5 hour and after that all the patients have tampon for 3 days, in addition to they have splint and mesh for one week on their nose. Initial outcome will be contain of erythema. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: Erythema will be studied on the basis of dermatologist opinion in this way: without, light, moderate and severe erythema. Initial outcome will be contain of itching. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: Itching will be studied on the basis of ten parts scale Visual Analogue Scale with asking from patient. Secondary outcome is containing of burning. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: Burning will be studied on the basis of ten parts scale Visual Analogue Scale with asking from patient. Secondary outcome is containing of acne. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Secondary outcome is containing of urticaria. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Secondary outcome is containing of macula. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Secondary outcome is containing of papula. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Secondary outcome is containing of allergic contact dermatitis. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Secondary outcome is containing of perioral dermatitis. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Secondary outcome is containing of seborrheic dermatitis. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Secondary outcome is containing of plaque. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Secondary outcome is containing of scabbing. Timepoint: Patients will be studied about skin effects 3 days later, one week later and one month later after surgery. Method of measurement: They will be studied on the basis of dermatologist opinion in 4 group: without, slight, moderate and severe events. Kermanshah University of Medical Science Approved 2022-01-29 Ethics committee of Kermanshah University of Medical Science Mohamadi Ave., Amirkabir Blvd., Kermanshah Town Kermanshah Kermanshah Iran (Islamic Republic of)