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

March 12, 2026 updated by: Amr Elsayed Tawfek Ibrahim, Zagazig University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharqia Province
      • Zagazig, Sharqia Province, Egypt, 44519
        • cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gentamycin
Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum
Procedure: Gentamycin
Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum.
Active Comparator: control
Patients in this group sternum will be closed without application of local Gentamycin containing collagen
Procedure: bone wax
Patients in this group sternum will be closed without application of local Gentamycin containing collagen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of infection severity (superficial and deep infections)
Time Frame: during first 3 months post operative
during first 3 months post operative
Incidence of adverse effects of gentamicin implants
Time Frame: during first 3 months post operative
during first 3 months post operative
Length of hospital stay
Time Frame: during first 3 months post operative
during first 3 months post operative
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.
during first 3 months post operative
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.

  1. Minimal union Rare/slight bone bridging across the osteotomy.
  2. Mild union Less than 25% bone bridging.
  3. Moderate union 25% to 50% bone bridging.
  4. Near-complete More than 50% bone bridging with high stability.
  5. Complete union Sternal halves well-aligned; no perceptible gap; looks like normal bone.
after 3 months non contrast C.T.chest done to assess degree of healing by the Six Points Scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: amr tawfeek, cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB#1355/18-5-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

by publication of the study

IPD Sharing Time Frame

after publication of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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