Rapid Sternal Closure System (TALON) (TALON)

April 5, 2011 updated by: Duke University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved
Time Frame: 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).
Baseline, Maximum value during postoperatively days 1 thru 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union
Time Frame: 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.
Up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

KLS Martin, L.P.

Investigators

  • Principal Investigator: Elliott Bennett-Guerrero, M. D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00006260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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