No registrations found.
ID
Source
Health condition
sternal closure , prevention of sternal complications after cardiac surgery, infection prevention and cardiac surgery
Sponsors and support
department of cardiothoracic surgery
Th.W.O.Elenbaas
Intervention
Outcome measures
Primary outcome
1. Dead within 30 days of operation;
2. Sternal wound infections (superfiscial, deep, organ-linked);
3. Sternal dehiscence.
Secondary outcome
Complants of sternal pain and sternal dehiscence after 1 year.
Background summary
Mediaan sternotomy is the approach in cardiac surgery and closure is done traditionally with steel wires , either in a single fashion or figure of eight configuration. One of the important outcome results is sternal dehiscence and or sternal infection. This is a complication with a high mortality and morbidity and around 20.000 euro extra coasts apart from the discomfort for the patients and worse outcome results.
The ZipFix sternal closure system is a new method for median sternotomy closure with tie -wrap like bands made of PEEK ( poly ether ether ketone). The null hypotheses is that ther is no difference in complications as sternal dehiscence and or sternal infections. Patients will be prospectively randomised and followed for these complications for 1 year.
Study objective
Sternal closure is done routinely with stainless steel wires. In some cases thes wires are cutting through the bone and a non stable sternotomy can cause pain and lead to serious infections of the sternum and mediastinum. We hypothese that a new method for sternal closure is safer and better then the old standard method.
Study design
1. At discharge;
2. 6 weeks after OR;
3. 1 year after OR through telephone.
Intervention
Patients are randomized with the program Edgar II. Randomization is between:
1. Closure of the sternum with stainless steel wires;
2. Closure of the sternum with ZIPFIX bands, made of polyether ether ketone (PEEK).
Th.W.O. Elenbaas
Eindhoven
The Netherlands
+31 (0)40 2398680
tedelenbaas@hotmail.com
Th.W.O. Elenbaas
Eindhoven
The Netherlands
+31 (0)40 2398680
tedelenbaas@hotmail.com
Inclusion criteria
1. Patients undergoing median sternotomy;
2. Age above 18 year.
Exclusion criteria
1. No informed consent;
2. Hypersensitivity to nickel;
3. Allergic to PEEK.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3204 |
NTR-old | NTR3355 |
Other | : SSZIPFIX |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |