Post Cardiac Surgery, Sternal Closure
Conditions
Brief summary
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
Interventions
PROCEDURETORQ assisted sternal closure
PROCEDUREConventional closure
Sponsors
St. Paul's Hospital, Canada
Kardium Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Referred for elective cardiac surgery at St Paul's Hospital * Expected to live greater than 12 months * Capable of giving written informed consent * Willing to participate in follow-up * Greater than 18 years of age, and of legal age of consent in host country
Exclusion criteria
* Patient has had previous median sternotomy, requiring redo sternotomy * Surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. Figure of 8 technique) * Surgeon has elected, prior to enrollment. to treat with the TORQ as a prophylactic measure (e.g. in high risk cases where use of the TORQ has been shown to be effective in preventing dehiscence)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory function | Pre-op, 2 and 4 days Post-op | — |
| Pain Score | 2, 4, 14, 30 and 90 days post op | Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking |
Countries
Canada
Outcome results
None listed