Rapid Sternal Closure System (TALON)

NCT00638014 | Completed Phase 4 Results DMC

• 1 other identifier: PRO00006260
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sternal Wound Infection; Mediastinitis

Keywords

Sternal wound closure; cardiac surgery; sternal nonunion

Outcome Measures

Primary Outcomes (1)

• Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved

  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).

  Baseline, Maximum value during postoperatively days 1 thru 7

Secondary Outcomes (1)

• Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union

  Up to 180 days

Study Arms (2)

1

ACTIVE COMPARATOR

Conventional wires only

Device: Conventional wire closure

2

EXPERIMENTAL

Rapid Sternal Closure System supplemented with wires

Device: Rapid Sternal Closure System

Interventions

Rapid Sternal Closure System DEVICE

Sternal talons will be used and supplemented with wires

2

Conventional wire closure DEVICE

Conventional wire closure of sternum

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Undergoing emergency cardiac surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed).
• Undergoing a significant concomitant surgical procedure (eg, carotid endarterectomy, aortic root repair or replacement, deep hypothermic circulatory arrest \[DHCA\], or pulmonary resection).
• Undergoing a minimally invasive or a thoracic surgical approach.
• Using a preoperative mechanical assist device or intraaortic balloon pump (IABP), if inserted for shock/low output syndrome (an IABP is allowed if it is inserted for unstable angina or low ejection fraction).
• Active and significant systemic infection, eg, active endocarditis or a history of significant recurrent systemic infection.
• Receiving antibiotic therapy within the 2 weeks before the date of surgery.
• History of malignancy within the past year (except for squamous or basal cell carcinoma of the skin that has been treated, with no evidence of recurrence).
• History of major organ transplantation, including bone marrow transplantation.
• Recent history of significant drug or alcohol abuse.
• Female subject who is pregnant (including a positive pregnancy test at screening or baseline) or nursing. Females of childbearing potential not practicing a birth control method with a high degree of reliability.
• Postsurgical life expectancy ≤ 90 days, in the investigator's or sponsor's opinion.
• Current participation or participation within 30 days before the start of this study in an experimental drug or device study or currently participating in a study during which the administration of investigational drugs within 90 days is anticipated.
• Refusal to accept medically indicated blood products.
• Moderate or severe pectus deformity.

Sponsors & Collaborators

• Duke University: lead
• KLS Martin, L.P.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (31)

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• Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup; American Academy of Orthopaedic Surgeons; American Association of Critical Care Nurses; American Association of Nurse Anesthetists; American College of Surgeons; American College of Osteopathic Surgeons; American Geriatrics Society; American Society of Anesthesiologists; American Society of Colon and Rectal Surgeons; American Society of Health-System Pharmacists; American Society of PeriAnesthesia Nurses; Ascension Health; Association of periOperative Registered Nurses; Association for Professionals in Infection Control and Epidemiology; Infectious Diseases Society of America; Medical Letter; Premier; Society for Healthcare Epidemiology of America; Society of Thoracic Surgeons; Surgical Infection Society. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004 Jun 15;38(12):1706-15. doi: 10.1086/421095. Epub 2004 May 26.

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MeSH Terms

Conditions

Mediastinitis

Condition Hierarchy (Ancestors)

Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Elliott Bennett-Guerrero
• Organization: Duke University

benne011@mc.duke.edu

9196819660

Study Officials

• Elliott Bennett-Guerrero, M. D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 18, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 2, 2011
• Results First Posted: May 2, 2011

Record last verified: 2011-04

Locations

US (1)