Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454643
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-05-26
Brief Title:
Gentamicin in Cardiac Surgery
Sponsor:
Al-Rasheed University College
Organization:
Al-Rasheed University College
Study Overview
Official Title:
The Pharmacological and Clinical Aspects of Using Gentamicin in Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Surgical site infection SSI is a serious postoperative complication after cardiac surgery that have a negative impact on a patients health and survival This study aims to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI with monitoring to the effective therapeutic level
Detailed Description:
Gentamicin is an aminoglycoside antibiotic that exhibits a wide range of antibacterial effects mostly targeting Gram-negative bacteria while its effectiveness against Gram-positive organisms is comparatively weaker Gentamicin has significant efficacy against multidrug-resistant bacteria as well Gentamicin is often used in conjunction with beta-lactam antibiotics to provide enhanced therapeutic efficacy via a synergistic effect particularly in cases of Gram-positive and multidrug-resistant bacterial infections
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None