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

NCT07470112 | Active Not Recruiting DMC

• 1 other identifier: ZU-IRB#1355/18-5-2025
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Site Infection (SSI)

Keywords

Poststernotomy,; Surgical Site Infection (SSI); local gentamycin containig collagen

Outcome Measures

Primary Outcomes (5)

• Rate of infection severity (superficial and deep infections)

  during first 3 months post operative

• Incidence of adverse effects of gentamicin implants

  during first 3 months post operative

• Length of hospital stay

  during first 3 months post operative

• short-term surgical outcome checklist

  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

  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

Study Arms (2)

gentamycin

EXPERIMENTAL

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

Procedure: Gentamycin

control

ACTIVE COMPARATOR

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

Procedure: bone wax

Interventions

Gentamycin PROCEDURE

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

gentamycin

bone wax PROCEDURE

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

control

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

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

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Gentamicins; bone wax

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• amr tawfeek

  cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ass prof

Model Details: 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. )

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 13, 2026
• Study Start: May 20, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after publication of the study

Locations

EG (1)