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

To compare the effect of removing Hemovac drains 24 hours versus 48 hours after lower limb orthopedic surgeries on drain microbial contamination, microbial diversity, surgical site infection, hematoma, wound dehiscence, pain severity, length of hospital stay, and overall clinical outcomes of patients.

Clinical trial with control group and intervention group, with parallel groups, single-blind on 180 people. Completely randomized block method for randomization

This randomized, single-blind clinical trial (blind assessor) will be conducted on orthopedic patients at Imam Khomeini Hospital in Sari. Patients will be randomly divided into two groups: removal of the Hemovac drain within 24 hours or 48 hours after surgery. At the time of drain removal, the last 5 cm of the drain will be cut sterilely and sent to the laboratory for microbial culture and antibiogram. Microbial contamination, bacterial species, and clinical complications (infection, hematoma, wound dehiscence, pain, length of stay, and antibiotic change) will be compared between the two groups.

Inclusion criteria: Type of surgery, age over 18 years, all patients with drains with closed lower limb orthopedic surgery with internal fixation, considering the patient's BMI. Exclusion criteria: Inability to remove the drain in patients with persistent discharge, active infection before surgery, changing the drain site or disrupting its function, patient's lack of cooperation in post-operative follow-up

In the intervention group, the drain will be removed after 24 hours, and in the control group, the hemovag drain will be removed after 48 hours.

Microbial contamination of the Hemovac drain tip

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.

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.