Use of GentaColl after median sternotomy

Use of GentaColl after median sternotomy - EIGEMS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003244

Enrollment

600

Registered

2011-08-31

Start date

2011-09-18

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

J98.50 T81.8 T81.4

Interventions

Group 1: Intervention group: Use of GentaColl, a gentamycin rich collagen sponge (Resorba) during closure of sternotomy, (to day: routinely used during closure of sternotomy) Group 2: historical cohor

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: elecriv cardiac surgery with median sternotomy

Exclusion criteria

Exclusion criteria: urgency cardiac surgery, transplatation, endocarditis

Design outcomes

Primary

Measure	Time frame
primary outcome: The use of GentaColl reduces the incidence of mediastinitis inbetween the 30 day follow-up after cardiac surgery with median sternotomy. The classification of surgical site infections is published by Horan et al (1992), the so called CDC classification.	—

Secondary

Measure	Time frame
hospital stay, ICU-stay, death, mild forms of surgical site infection, delir	—

Countries

Germany

Contacts

Public ContactKatrin Plötze

Herzzentrum Dresden Universitätsklinik, Klinik für Herzchirurgie

k.ploetze@herzzentrum-dresden.com+49 351-450-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026