Surgical Site Infection (SSI)
Conditions
Keywords
Poststernotomy,, Surgical Site Infection (SSI), local gentamycin containig collagen
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.
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.
Interventions
PROCEDUREGentamycin
Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum.
PROCEDUREbone wax
Patients in this group sternum will be closed without application of local Gentamycin containing collagen.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
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. )
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | during first 3 months post operative | Reduce mediastinits and improve sternum healing in relation to different types of of sternum closure. |
| assess degree of healing | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORamr tawfeek
cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
Outcome results
None listed