NCT06454643

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
Last Updated

June 12, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 26, 2024

Last Update Submit

June 6, 2024

Conditions

Cardiac Infection

Keywords

infectionantibioticsantimicrobial prophylaxisaminoglycosideGentamicin

Outcome Measures

Primary Outcomes (4)

  • 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.

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Drug: Flucloxacillin and ceftriaxone

Gentamicin

EXPERIMENTAL

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.

Drug: Flucloxacillin and gentamicin

Interventions

Flucloxacillin and gentamicinDRUG

This intervention aimed to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI.

Gentamicin
Flucloxacillin and ceftriaxoneDRUG

Control group

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The research included individuals of both genders.
  • Patients aged 18 and above.
  • Patients had undergone any type of cardiac surgery.

You may not qualify if:

  • Patients having a prior diagnosis of organ failure.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baghdad Medical City

Baghdad, 10011, Iraq

Location

Related Publications (2)

  • 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.

    PMID: 33859725RESULT

  • 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.

    PMID: 23837413RESULT

MeSH Terms

Conditions

Infections

Interventions

FloxacillinGentamicinsCeftriaxone

Intervention Hierarchy (Ancestors)

CloxacillinOxacillinPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCefotaximeCephacetrileCephalosporinsThiazines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2024

First Posted

June 12, 2024

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

June 12, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)