NCT01647178CompletedNot Applicable
The Influence of the TORQ Sternal Closure Assistance Device on Post-Operative Pain, Pulmonary Function and Quality of Life Compared to Traditional Manual Wire Closure: A Randomized Controlled Trial.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kardium Inc.
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- Respiratory function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Respiratory function
Time Frame: Pre-op, 2 and 4 days Post-op
Pain Score
Time Frame: 2, 4, 14, 30 and 90 days post op
Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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