Efficacy of Local Gentamicin Containing Collagen In Prevention of Post Stermotomy Infection In Cardiac Surgery

Zagazig University

Status: Active, not recruiting

Conditions: Surgical Site Infection (SSI)

Treatments: Procedure: Gentamycin; Procedure: bone wax

Study type: Interventional

Funder types: Other

Identifiers

NCT07470112

ZU-IRB#1355/18-5-2025

Details and patient eligibility

About

The local application of gentamicin-containing collagen implants reduces the incidence of surgical site infections in high-risk cardiac surgery patients compared to standard prophylactic measures alone.

Full description

Surgical procedure:

• Standard median sternotomy and cannulation for cardiopulmonary bypass. All procedures will be performed on heparin bonded cardiopulmonary bypass circuits with a membrane oxygenator.
• Closure technique: Patients in our study will be divided into two groups: Gentamycin Group: Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum.

(Gentamycincontaining collagen will be applied to retrosternal and between both sternal halves similar to bone wax just prior to sternal wiring (T-SHAPED. ) Control Group: Patients in this group sternum will be closed without application of local Gentamycin containing collagen.

Enrollment: 142 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:. Old age > 60 years old.

• Uncontrolled hypertension and diabetes mellitus patients.
• Obesity (BMI>30 kg/m2).
• Female gender.
• Osteoporosis of the sternum.
• Chronic Obstructive Pulmonary Disease (COPD).
• Steroid therapy or immunosuppression.
• Intraoperative intra-aortic balloon pump (IABP) use.
• Re-exploration for bleeding.
• Long time of cardiopulmonary bypass (>180 minutes).
• Redo cardiac surgery operation (elective )

Exclusion Criteria:

• o Patients with known allergies to gentamicin.

  • Patients less than 18 years old.
  • Off-pump cardiac surgery.
  • Minimal invasive cardiac surgery.
  • Elevated serum creatinine level.
  • Emergent cases
  • Harvesting of Bilateral internal thoracic artery.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

gentamycin

Experimental group

Description:

Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum

Treatment:

Procedure: Gentamycin

control

Active Comparator group

Description:

Patients in this group sternum will be closed without application of local Gentamycin containing collagen

Treatment:

Procedure: bone wax