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

N/AActive Not RecruitingNCT07470112

Zagazig University142 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

142

Conditions

Surgical Site Infection (SSI)

Interventions

GentamycinPROCEDURE

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

bone waxPROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

Rate of infection severity (superficial and deep infections)

Time frame: during first 3 months post operative

Incidence of adverse effects of gentamicin implants

Time frame: during first 3 months post operative

Length of hospital stay

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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