Sternum refixatie met behulp van ZipFix.

A new sternal closure method with ZipFix.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22106

Enrollment

600

Registered

2012-03-01

Start date

2012-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

sternal closure , prevention of sternal complications after cardiac surgery, infection prevention and cardiac surgery

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).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing median sternotomy; 2. Age above 18 year.

Exclusion criteria

Exclusion criteria: 1. No informed consent; 2. Hypersensitivity to nickel; 3. Allergic to PEEK.

Design outcomes

Primary

Measure	Time frame
1. Dead within 30 days of operation; 2. Sternal wound infections (superfiscial, deep, organ-linked); 3. Sternal dehiscence.	—

Secondary

Measure	Time frame
Complants of sternal pain and sternal dehiscence after 1 year.	—

Contacts

Public ContactTh.W.O. Elenbaas

Catharina Ziekenhuis Eindhoven

tedelenbaas@hotmail.com+31 (0)40 2398680

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)