Autologous Platelet-Leukocyte Gel Therapy during sternum closure in cardiac surgery patients at risk for post-operative infection.

Completed

• Conditions: mediastinitis; post-operative infection; woundinfection; 10004018; 10007593

• Registration Number: NL-OMON29722
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 700

Inclusion Criteria

indication for cardiac surgery
planned medial sternotomy
high risk for post-operative infection
signed informed consent by patient

Exclusion Criteria

emergency surgery
active endocarditis
pre-exsisting infection/use of antibiotics
age beneath 18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of sternal wound infections during the first 90 days after surgery </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Total amount of postoperative blood loss<br /><br>• Amount of blood products given<br /><br>• Incidence of non-healing wounds<br /><br>• Incidence of vessel harvest site infections<br /><br>• Pain sensation at sternal wound and vessel harvest site(s)<br /><br>• Use of pain medication </p><br>