ocal antibiotics in the treatment of wound infections after cardiac surgery

• Conditions: Post-sternotomy mediastinitis; MedDRA version: 17.1Level: PTClassification code 10027082Term: MediastinitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-001170-33-NL
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-08
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Age > 18 years
-Underwent a cardiothoracic procedure through median sternotomy
-Clinical signs of PSM as described by the Centres for Disease Control and Prevention (CDC)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Patients with severe renal failure (serum creatinine >150 µmol/L)
-Patients with neuromuscular diseases
-Patients who are allergic for aminoglycosides
-Patients with systemic lupus erythematosus, scleroderma or chronic polyarthritis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of our study is to evaluate clinical outcomes of patients primarily closed over Redon catheters for the treatment of post-sternotomy mediastinitis, comparing the application of local gentamicin with a control group. ;Secondary Objective: Not applicable;Primary end point(s): In hospital stay;Timepoint(s) of evaluation of this end point: Hospital discharge

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): In-hospital mortality<br>Duration of wound sterilization<br>Duration of antibiotic treatment<br>Duration of drainage<br>CRP decline<br>Leukocyte decline<br>;Timepoint(s) of evaluation of this end point: Hospital discharge