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Surgical site infection (SSI) is a serious postoperative complication after cardiac surgery that have a negative impact on a patient's 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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Patients received flucloxacillin and ceftriaxone 60 minute before incision and then continued for 48 hours as follows:
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| Gentamicin | Experimental | Patients received flucloxacillin and gentamicin 60 minute before incision and then continued for 48 hours, as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flucloxacillin and gentamicin | Drug | This intervention aimed to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| White blood cells | White blood cells count (WBCs per microliter). | Up to 5 days post-surgery |
| Hemoglobin level | Hemoglobin concentration (g/dl). | Up to 5 days post-surgery. |
| Erythrocyte sedimentation rate | Erythrocyte sedimentation rate (millimeters per hour). | Up to 5 days post-surgery. |
| Body temperature | Body temperature measurement (Degrees Celsius °C). | Up to 5 days post-surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baghdad Medical City | Baghdad | 10011 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33859725 | Result | 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. | |
| 23837413 | Result | 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. |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D005436 | Floxacillin |
| D005839 | Gentamicins |
| D002443 | Ceftriaxone |
| ID | Term |
|---|---|
| D003023 | Cloxacillin |
| D010068 | Oxacillin |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Flucloxacillin and ceftriaxone | Drug | Control group |
|
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D013843 | Thiazines |