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IRCT20200219046557N1 IRCT 2020-03-26 Tabriz University of Medical Sciences Evaluation of the effects of surgicel in open prostatectomy surgery Comparison of Open Prostatectomy Patients In terms of Bleeding and Operative site Infection,with and without Surgicel 2018-09-23 anticipated 30 Complete https://irct.ir/trial/46049 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random method: Block, Random unit: individual, Random Tool: Random Block 4. for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, dice drooped and the block number will be selected. this procedure continued to completed the allocation and reached to sample size, Blinding description: This is a double-blinded study and Researcher and patients are kept unaware of intervention in each group and In order to allocation concealment, the type of intervention will be written on paper and placed in numbered, matte and packed envelopes.The envelopes will be opened in the order of participation of the participants and the type of group will be determined. N/A Open prostatectomy. Intervention 1: Intervention group: Surgicel (a topical cellulose homeostatic agent) will be used to control bleeding. Intervention 2: Control group:Bleeding is controlled by an electrocautery (without the use of surgical). Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed. To whom: ll Physicians and residents of the department of Conditions: After obtaining permission from the deputy research of group Where to obtain: Person responsible for scientific accountability of study How to obtain: First approved by the Research Vice-President Comments:
public Hamed Dadashkarimi
Department of Urology,Imam Reza Hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) 5155969748 0413347054 dadashkarimihamed@gmail.com Tabriz University of Medical Sciences scientific Mohsen Amjadi
Imam Reza hospital, Golgasht st.
Tabriz Iran (Islamic Republic of) 5155969748 +98 41 3334 7054 amjadm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patient who are candidates for open prostatectomy Patients aged 40 to 90 years Having informed consent to participate in the study 40 years 90 years Male Existence of an bleeding disorder History of previous prostatic or urethral surgery; (c) Having bladder stone. Treatment - Surgery Treatment - Surgery Intervention group: Surgicel (a topical cellulose homeostatic agent) will be used to control bleeding Control group:Bleeding is controlled by an electrocautery (without the use of surgical) Hemoglobin level. Timepoint: Preoperative, postoperative, days 2 and 3. Method of measurement: According to the lab and on the basis grams per deciliter. Intraoperative blood loss. Timepoint: At the end of surgery. Method of measurement: The volume of blood absorbed by surgical gauze was estimated using Gauze Visual Analogue method. The mentioned figures plus the amount of blood in the surgical suction pump was considered as the total amount of intraoperative blood loss. Hematocrit. Timepoint: Preoperative, postoperative, days 2 and 3. Method of measurement: According to the lab and on the basis percent. Infection. Timepoint: 7 days after surgery. Method of measurement: Redness,secretion, tenderness in the wound or wound dehiscence. Tabriz University of Medical Sciences Approved 2020-02-17 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Science , Gholghasht street , Azadi street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)