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Post-operative sternal closure related complications of zipfix versus sternal closure for one year in patients undergoing cardiac surgery

Investigating complications of ZipFix versus conventional sternal closure in patients undergoing cardiac surgery: one-year follow-up

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016070719316N2
Enrollment
326
Registered
2016-07-25
Start date
2014-02-02
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Mechanical complication of coronary artery bypass and valve grafts. Mechanical complication of coronary artery bypass and valve grafts

Interventions

Intervention 1: Intervention group: Two steel wires were used through the manubrium
then five zipfix(synthes GmbH, Oberdorf, Switzerland) a biocompatible poly-ether-ether-ketone cable tie based sternal closure device brought on the market in 2010, were used to close the sternum by pa
Treatment - Surgery
Intervention group: Two steel wires were used through the manubrium
Control group: The sternum is closed by passing eight sternal steel wires in total. Two through the manubrium and the remaining sternal wires were used to close the sternum by passing the wired from

Sponsors

Vice Chancellor for Research - Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Those who were candidate for cardiac surgery Exclusion Criteria: preexisting autoimmune diseases; asthma; connective tissue disorders; as well as Sternal infection

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sternal Infection. Timepoint: postoperatively as well as 1, 3, 6, and 12 months after discharge. Method of measurement: Visiting patients and viewing sites of sternal closure.

Secondary

MeasureTime frame
Dehiscence. Timepoint: postoperatively as well as 1, 3, 6, and 12 months after discharge. Method of measurement: Visiting patients and viewing sites of sternal closure.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPouya Nezafati

Mashhad University of Medical Sciences

nezafatip871@mums.ac.ir+51 36090800

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026