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NCT Number: NCT07470112

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Surgical Site Infection (SSI) Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gentamycin

Procedure

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

bone wax

Procedure

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

Primary outcomes

  1. Rate of infection severity (superficial and deep infections)

    Time frame: during first 3 months post operative

  2. Incidence of adverse effects of gentamicin implants

    Time frame: during first 3 months post operative

  3. Length of hospital stay

    Time frame: during first 3 months post operative

  4. short-term surgical outcome checklist

    Time frame: during first 3 months post operative

    Reduce mediastinits and improve sternum healing in relation to different types of of sternum closure.

  5. assess degree of healing

    Time frame: after 3 months non contrast C.T.chest done to assess degree of healing by the Six Points Scale

    non contrast C.T.chest done to assess degree of healing by The 6-Point CT Score (Stacy Score):

    0 Non-union No evidence of bone bridging; wide gap.

    • Minimal union Rare/slight bone bridging across the osteotomy.
    • Mild union Less than 25% bone bridging.
    • Moderate union 25% to 50% bone bridging.
    • Near-complete More than 50% bone bridging with high stability.
    • Complete union Sternal halves well-aligned; no perceptible gap; looks like normal bone.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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