Trial Outcomes & Findings for Rapid Sternal Closure System (TALON) (NCT NCT00638014)

Results Overview

Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

Baseline, Maximum value during postoperatively days 1 thru 7

Results posted on

2011-05-02

Participant Flow

Subjects were consented and enrolled in the study at 2 centers from April 2008 to July 2009.

Overall 53 subjects were consented and enrolled in the study from April 2008 to July 2009. Two patients were not included in the analysis (1 patients' surgery was cancelled, 1 patient was not randomized due to logistical reasons), leaving a total of 51 subjects who were included in the modified intent-to-treat analysis.

Participant milestones

Participant milestones
Measure	Conventional Wires Only The control group received conventional wires including double wires to close the sternum.	Talon Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
Overall Study STARTED	23	28
Overall Study COMPLETED	23	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rapid Sternal Closure System (TALON)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Wires Only n=23 Participants The control group received conventional wires including double wires to close the sternum.	Talon n=28 Participants Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Age Continuous	63.0 years STANDARD_DEVIATION 9.2 • n=5 Participants	61.8 years STANDARD_DEVIATION 10.0 • n=7 Participants	62.4 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	24 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	28 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Maximum value during postoperatively days 1 thru 7

Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).

Outcome measures

Outcome measures
Measure	Conventional Wires Only n=23 Participants The control group received conventional wires including double wires to close the sternum.	Talon n=28 Participants Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved	58 percentage change Standard Deviation 24	67 percentage change Standard Deviation 32

SECONDARY outcome

Timeframe: Up to 180 days

The Data and Safety Monitoring Board reviewed source documents for all cases with possible sternal wound infection and sternal instability or non-union and made a determination as to the presence of these complications.

Outcome measures

Outcome measures
Measure	Conventional Wires Only n=23 Participants The control group received conventional wires including double wires to close the sternum.	Talon n=28 Participants Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union	1 Participants	1 Participants

Adverse Events

Conventional Wires Only

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Talon

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Conventional Wires Only n=23 participants at risk The control group received conventional wires including double wires to close the sternum.	Talon n=28 participants at risk Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
Renal and urinary disorders Renal failure	4.3% 1/23 • Number of events 1	0.00% 0/28
Surgical and medical procedures Chest tube entrapment between sternal halves (not Talon)	0.00% 0/23	3.6% 1/28 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Elliott Bennett-Guerrero

Duke University

Phone: 9196819660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place