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Sternum refixatie met behulp van ZipFix.


- candidate number11259
- NTR NumberNTR3355
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2012
- Secondary IDsSSZIPFIX 
- Public TitleSternum refixatie met behulp van ZipFix.
- Scientific TitleA new sternal closure method with ZipFix.
- ACRONYM
- hypothesisSternal 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) studiedCardiac surgery, Prevention, Infection, Sternal closure
- Inclusion criteria1. Patients undergoing median sternotomy;
2. Age above 18 year.
- Exclusion criteria1. No informed consent;
2. Hypersensitivity to nickel;
3. Allergic to PEEK.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate1-mrt-2014
- Target number of participants600
- InterventionsPatients 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 outcome1. Dead within 30 days of operation;
2. Sternal wound infections (superfiscial, deep, organ-linked);
3. Sternal dehiscence.
- Secondary outcomeComplants of sternal pain and sternal dehiscence after 1 year.
- Timepoints1. At discharge;
2. 6 weeks after OR;
3. 1 year after OR through telephone.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Th.W.O. Elenbaas
- CONTACT for SCIENTIFIC QUERIES Th.W.O. Elenbaas
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven, Department of cardiothoracic surgery
- PublicationsN/A
- Brief summaryMediaan 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)
- RECORD1-mrt-2012 - 30-mrt-2012


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