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IRCT20251113067985N1 IRCT 2025-12-05 Mazandaran University of Medical Sciences Examining the best time to remove the drain (drainage tube) after lower limb bone and joint surgery Studying the effect of the duration of hemovac drain placement 24 hours vs. 48 hours after lower limb orthopedic surgeries on the rate of microbial contamination and clinical outcomes of patients 2025-12-06 anticipated 180 Complete https://irct.ir/trial/87613 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, samples were selected using simple random sampling. In this study, patients hospitalized in the orthopedic department who underwent orthopedic surgery of the lower extremities and had a hemovac drain inserted and met the conditions for entry into the study were listed. To allocate individuals to the control and intervention groups, a block randomization method was used to maintain a balance in the number of participants in the two groups. In this way, the patient list was numbered and random number generation software (Excel) was used. Small blocks of 4 or 6 people were created, the order within each block was randomly determined, and the patients were placed in the control and intervention groups in the same order, and finally 90 people were placed in the control group and 90 people in the intervention group without the researcher having any non-random interference in their selection or allocation, Blinding description: The study is single-blinded and the evaluator will be unaware of the grouping of the participants in the study. In this study, we will have two groups. In one group, the hemovac drain will be removed 24 hours after the operation and in the other group, the hemovac drain will be removed 48 hours after the operation. The allocation of patients to the study groups will be based on a randomized block design. N/A Lower limb orthopedic surgeries. Intervention 1: Intervention group: Intervention group: Drain will be removed 24 hours after surgery. Intervention 2: Control group: Intervention group: Drain will be removed 48hours after surgery. 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 No more information available.
public Shayda Dolatkhah
No. 58, Sabalan Alley 14, Sabalan Town
Ardabil Iran (Islamic Republic of) 5619766744 +98 914 455 1277 sheydadolatkhah@gmail.com Mazandaran University of Medical Sciences scientific Sadegh Taheri
Mazandaran University of Medical Sciences, Farahabad
Sari Iran (Islamic Republic of) 4815733971 +98 914 455 1277 kouhikosar98@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Type of surgery Age over 18 years All patients with drains with closed lower limb orthopedic surgery with internal fixation Considering patient BMI 18 years no limit Both Inability to remove drain in patients with persistent discharge Active infection before surgery Changing the location of the drain or disrupting its function Patient's lack of cooperation in post-surgical follow-up Y79 Orthopedic devices associated with adverse incidents Prevention Prevention Intervention group: Intervention group: Drain will be removed 24 hours after surgery Control group: Intervention group: Drain will be removed 48hours after surgery Hemovac drain contamination. Timepoint: 24 hours. Method of measurement: Antibiogram test (antibiotic resistance and sensitivity) based on CLSI protocol. Wound infection (temperature above 38 degrees, redness, pain, and discharge). Timepoint: On days 14, 7, 3 and 21 after surgery. Method of measurement: Based on standard guidelines from the Centers for Disease Control and Prevention (CDC). Wound dehiscence. Timepoint: On days 14, 7, 3 and 21 after surgery. Method of measurement: Based on standard guidelines from the Centers for Disease Control and Prevention (CDC). Mazandaran University of Medical Sciences Approved 2025-11-20 Ethics committee of Mazandaran University of Medical Sciences No. 58, 14 Sabalan Alley, Phase one Ardabil Ardabil Iran (Islamic Republic of)