|- candidate number||11259|
|- NTR Number||NTR3355|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-mrt-2012|
|- Secondary IDs||SSZIPFIX |
|- Public Title||Sternum refixatie met behulp van ZipFix.|
|- Scientific Title||A new sternal closure method with ZipFix.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Cardiac surgery, Prevention, Infection, Sternal closure|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2012|
|- planned closingdate||1-mrt-2014|
|- Target number of participants||600|
|- Interventions||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).
|- 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.|
|- Timepoints||1. At discharge;|
2. 6 weeks after OR;
3. 1 year after OR through telephone.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Th.W.O. Elenbaas|
|- CONTACT for SCIENTIFIC QUERIES|| Th.W.O. Elenbaas|
|- Sponsor/Initiator ||Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|Catharina Hospital Eindhoven, Department of cardiothoracic surgery|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||1-mrt-2012 - 30-mrt-2012|