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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29722

Enrollment

700

Registered

2006-08-31

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mediastinitis post-operative infection woundinfection

Interventions

Patients randomized to the APLG group will receive APLG in the sternal wound, and if graft material is harvested, to the harvest site wound(s) as well. From each patient approximately 20% of circula

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of sternal wound infections during the first 90 days after surgery	—

Secondary

Measure	Time frame
• Total amount of postoperative blood loss • Amount of blood products given • Incidence of non-healing wounds • Incidence of vessel harvest site infections • Pain sensation at sternal wound and vessel harvest site(s) • Use of pain medication	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)