Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-01-01
2021-01-01
Brief Summary
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Detailed Description
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This study aims to evaluate the efficacy of administering gentamicin in combination with flucloxacillin as a pre-medication and for 48 hours after surgery in reducing the incidence of surgical site infections in patients undergoing cardiac surgeries, as compared to using a combination of ceftriaxone and flucloxacillin. Additionally, the study aimed to observes the therapeutic level of gentamicin required to achieve an effective concentration of the drug.
A prospective comparative study was conducted using an appropriate sample of 50 Iraqi patients undergone several types of cardiac surgeries.
A total of 50 patients (34 males and 16 females) between the ages of 18 and 75 were included in this study. These patients were admitted to the Surgical Department of the Iraqi Center for Heart Disease over a one-year period from January 2020 to January 2021. All patients underwent various types of cardiac surgery, such as coronary artery bypass graft (CABG), valve replacement, or device placement. The same surgical and anesthesia teams conducted the procedures.
A computerized randomization method was used to allocate patients into two groups in a randomized manner. Following the first interview, the patients were sequentially assigned numbers and then randomized into two groups via the online program Research Randomizer
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
Patients received flucloxacillin and ceftriaxone 60 minute before incision and then continued for 48 hours as follows:
* Flucloxacillin 2g given before surgery then 1g \* 4 for 48 hours after operation.
* Ceftriaxone 1g given before surgery then 1g \* 2 for 48 hours after operation.
Flucloxacillin and ceftriaxone
Control group
Gentamicin
Patients received flucloxacillin and gentamicin 60 minute before incision and then continued for 48 hours, as follows:
* Flucloxacillin 2g given before surgery then 1g \* 4 for 48 hours after operation.
* Gentamicin 2mg/kg of ideal body weight given before surgery, then 80 mg \*3 for 48 hours after surgery.
Flucloxacillin and gentamicin
This intervention aimed to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI.
Interventions
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Flucloxacillin and gentamicin
This intervention aimed to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI.
Flucloxacillin and ceftriaxone
Control group
Eligibility Criteria
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Inclusion Criteria
* Patients aged 18 and above.
* Patients had undergone any type of cardiac surgery.
Exclusion Criteria
* Patients already on antibiotics.
* Patients with elevated baseline renal function test before operation.
* Patients with contraindications to any of the prescribed medications were excluded from this study.
18 Years
75 Years
ALL
No
Sponsors
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Al-Rasheed University College
OTHER
Responsible Party
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Locations
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Baghdad Medical City
Baghdad, , Iraq
Countries
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References
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Ackah JK, Neal L, Marshall NR, Panahi P, Lloyd C, Rogers LJ. Antimicrobial prophylaxis in adult cardiac surgery in the United Kingdom and Republic of Ireland. J Infect Prev. 2021 Mar;22(2):83-90. doi: 10.1177/1757177420971850. Epub 2020 Nov 24.
White RW, West R, Howard P, Sandoe J. Antimicrobial regime for cardiac surgery: the safety and effectiveness of short-course flucloxacillin (or teicoplanin) and gentamicin-based prophylaxis. J Card Surg. 2013 Sep;28(5):512-6. doi: 10.1111/jocs.12155. Epub 2013 Jul 9.
Other Identifiers
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AR200311
Identifier Type: -
Identifier Source: org_study_id
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