Active — Not RecruitingNot Applicable

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

Egypt142 participantsStarted 2025-05-20

Plain-language 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.

Who can participate

Age range20 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Rate of infection severity (superficial and deep infections)

Timeframe: during first 3 months post operative

Incidence of adverse effects of gentamicin implants

Timeframe: during first 3 months post operative

Length of hospital stay

Timeframe: during first 3 months post operative

short-term surgical outcome checklist

Timeframe: during first 3 months post operative

assess degree of healing

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

Trial details

NCT IDNCT07470112

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Surgical Site Infection (SSI) trials

Who can participate

Age range20 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Rate of infection severity (superficial and deep infections)

Timeframe: during first 3 months post operative

Incidence of adverse effects of gentamicin implants

Timeframe: during first 3 months post operative

Length of hospital stay

Timeframe: during first 3 months post operative

short-term surgical outcome checklist

Timeframe: during first 3 months post operative

assess degree of healing

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