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…
ID
Bron
Aandoening
sternal closure , prevention of sternal complications after cardiac surgery, infection prevention and cardiac surgery
Ondersteuning
department of cardiothoracic surgery
Th.W.O.Elenbaas
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Dead within 30 days of operation;<br>
2. Sternal wound infections (superfiscial, deep, organ-linked);<br>
3. Sternal dehiscence.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1. At discharge;
2. 6 weeks after OR;
3. 1 year after OR through telephone.
Onderzoeksproduct en/of interventie
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).
Publiek
Th.W.O. Elenbaas
Eindhoven
The Netherlands
+31 (0)40 2398680
tedelenbaas@hotmail.com
Wetenschappelijk
Th.W.O. Elenbaas
Eindhoven
The Netherlands
+31 (0)40 2398680
tedelenbaas@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients undergoing median sternotomy;
2. Age above 18 year.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. No informed consent;
2. Hypersensitivity to nickel;
3. Allergic to PEEK.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3204 |
NTR-old | NTR3355 |
Ander register | : SSZIPFIX |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |