Clinical trial NCT05439395: Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
Official title: Multi Center, International, Single-arm, Retrospective, Observational Post Market Clinical Follow-Up (PMCF) Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Cardiac Valve Insufficiency
Aortic Valve Stenosis
Keywords: Median Sternotomy
Partial Sternotomy
Coronary Artery Bypass Grafting (CABG)
Cardiac Valve Replacement
Cardiac Valve Reconstruction
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2022-06-30
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving a partial or a complete sternotomy closed with Steelex Sternum Set participating either in the OPTICABG or PREMIVALVE study.

Brief summary: The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the "OPTICABG" as well as in the "PREMIVALVE" study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. "OPTICABG" patients were followed up 3 months after surgery and "PREMIVALVE" patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.


Eligibility criteria: Inclusion Criteria:

* OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
* PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
* Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent
* Age ≥18 years

Exclusion Criteria:

* OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.

Primary outcomes:
measure: Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection
timeFrame: up to 6 months after surgery
Secondary outcomes:
measure: Incidence of sternum instability
timeFrame: up to 6 months after surgery
measure: Incidence of sternum dehiscence
timeFrame: up to 6 months after surgery
measure: Incidence of superficial and deep sternal wound infection
timeFrame: up to 6 months after surgery
measure: Incidence of other cardiac and cerebral complications
timeFrame: up to 6 months after surgery
measure: Incidence of suture related complications
timeFrame: up to 6 months after surgery
measure: Length of hospital stay
timeFrame: until discharge (approximately 10 days postoperative)
measure: Length of intensive care unit stay
timeFrame: until discharge (approximately 10 days postoperative)
measure: Health Status measured with EQ-5D-5L Score
timeFrame: up to 6 months after surgery
measure: Intraoperative handling of the Steelex® Sternum Set
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch KH Stuttgart
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
Study officials:
References: