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 range

20 Years – 70 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

20 Years – 70 Years

Sex

ALL

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