CompletedPhase 4

Rapid Sternal Closure System (TALON)

United States51 participantsStarted 2008-03

Plain-language summary

The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves early postoperative recovery as manifested by decreased pain and improved pulmonary function. Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs (surgical wound complication defined as surgically treated sternal wound infection and sternal instability/non-union) as outlined in the protocol. For a given study endpoint, the null hypothesis will be no difference between the Rapid Sternal Closure System group and the control group. The alternative hypothesis will be a difference between 2 groups. The statistical objective of this study is to reject the null hypothesis in favor of the alternative hypothesis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female. Women of childbearing potential must have a negative serum (or urine) human chorionic gonadotropin assay prior to surgery, and be willing to continue to use effective means of birth control for at least 180 days following surgery. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B(TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
✓. Age ≥ 18 years.
✓. Scheduled to undergo nonemergent on or off pump coronary artery bypass graft (CABG) and/or valve repair or replacement surgery through a full median sternotomy.
✓. At higher risk for SWC, defined as the presence of any of the following factors: obesity (body mass index \> 30), chronic steroid use (\>6 month duration and currently using), severe chronic obstructive pulomonary disease, planned bilateral internal mammary artery harvest, undergoing redo median sternotomy, and history of radiation to the chest.
✓. Willing and able to provide written informed consent.
✓. Available for evaluation from baseline until final evaluation at 180 days postsurgery.

Exclusion criteria

What they're measuring

Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved

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

Trial details

NCT IDNCT00638014

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-07

Results submitted2011-02-23

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