Rapid Sternal Closure System (TALON)

This study has been completed.
Sponsor:
Collaborator:
KLS Martin, L.P.
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00638014
First received: March 12, 2008
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Sternal Wound Infection
Mediastinitis
Device: Rapid Sternal Closure System
Device: Conventional wire closure
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Phase 4 Study of Sternal Plating (Rapid Sternal Closure System, KLS Martin L.P.) in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Complications.

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved [ Time Frame: Baseline, Maximum value during postoperatively days 1 thru 7 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union [ Time Frame: Up to 180 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 51
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Conventional wires only
Device: Conventional wire closure
Conventional wire closure of sternum
Experimental: 2
Rapid Sternal Closure System supplemented with wires
Device: Rapid Sternal Closure System
Sternal talons will be used and supplemented with wires

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Age ≥ 18 years.
  3. 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.
  4. 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.
  5. Willing and able to provide written informed consent.
  6. Available for evaluation from baseline until final evaluation at 180 days postsurgery.

Exclusion Criteria:

  1. Undergoing emergency cardiac surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed).
  2. Undergoing a significant concomitant surgical procedure (eg, carotid endarterectomy, aortic root repair or replacement, deep hypothermic circulatory arrest [DHCA], or pulmonary resection).
  3. Undergoing a minimally invasive or a thoracic surgical approach.
  4. 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).
  5. Active and significant systemic infection, eg, active endocarditis or a history of significant recurrent systemic infection.
  6. Receiving antibiotic therapy within the 2 weeks before the date of surgery.
  7. 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).
  8. History of major organ transplantation, including bone marrow transplantation.
  9. Recent history of significant drug or alcohol abuse.
  10. Current immunosuppressive condition (eg, symptomatic human immunodeficiency virus [HIV] infection). Use of steroids is not an exclusion criteria).
  11. 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.
  12. Postsurgical life expectancy ≤ 90 days, in the investigator's or sponsor's opinion.
  13. 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.
  14. Refusal to accept medically indicated blood products.
  15. Moderate or severe pectus deformity.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00638014

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
KLS Martin, L.P.
Investigators
Principal Investigator: Elliott Bennett-Guerrero, M. D. Duke University
  More Information

Publications:
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. Epub 2004 May 26. Review.

Responsible Party: Gary Moore/ Regulatory Affair, Quality Assurance, KLS Martin, L.P.
ClinicalTrials.gov Identifier: NCT00638014     History of Changes
Other Study ID Numbers: PRO00006260
Study First Received: March 12, 2008
Results First Received: February 23, 2011
Last Updated: April 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Sternal wound closure
cardiac surgery
sternal nonunion

Additional relevant MeSH terms:
Mediastinitis
Wound Infection
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014