Sternal Wound InfectionPhase 4TALONNCT00638014
Rapid Sternal Closure System (TALON)
A Phase 4 study testing Rapid Sternal Closure System and Conventional wire closure in people with Sternal Wound Infection and Mediastinitis, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternal Wound Infection, Mediastinitis
- What is being tested?
- Rapid Sternal Closure System and Conventional wire closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Current immunosuppressive condition (eg, symptomatic human immunodeficiency virus [HIV] infection). Use of steroids is not an exclusion criteria).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
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
- Being tested
- Rapid Sternal Closure System, Conventional wire closure
- Keywords
- Sternal wound closure, cardiac surgery, sternal nonunion
- Medical subject headings
- Mediastinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Sternal Closure SystemDevice
Sternal talons will be used and supplemented with wires
Conventional wire closureDevice
Conventional wire closure of sternum
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Conventional wires only Receives: Device: Conventional wire closure |
| 2 | Experimental | Rapid Sternal Closure System supplemented with wires Receives: Device: Rapid Sternal Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Maximum value during postoperatively days 1 thru 7
Secondary outcomes (1)
Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union
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.
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Sternal Wound InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- KLS Martin, L.P.
- Investigators
- Elliott Bennett-Guerrero, M. D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638014
- Sponsor's protocol ID
- PRO00006260
- Acronym
- TALON
- Status last verified
- Apr 2011
- First submitted
- 12 Mar 2008
- Last updated
- 2 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fry DE. The economic costs of surgical site infection. Surg Infect (Larchmt). 2002;3 Suppl 1:S37-43. doi: 10.1089/sur.2002.3.s1-37.
PubMed 12573038Friberg O, Dahlin LG, Levin LA, Magnusson A, Granfeldt H, Kallman J, Svedjeholm R. Cost effectiveness of local collagen-gentamicin as prophylaxis for sternal wound infections in different risk groups. Scand Cardiovasc J. 2006 Apr;40(2):117-25. doi: 10.1080/14017430500363024.
PubMed 16608782Demmy TL, Park SB, Liebler GA, Burkholder JA, Maher TD, Benckart DH, Magovern GJ Jr, Magovern GJ Sr. Recent experience with major sternal wound complications. Ann Thorac Surg. 1990 Mar;49(3):458-62. doi: 10.1016/0003-4975(90)90256-6.
PubMed 2310254Tang GH, Maganti M, Weisel RD, Borger MA. Prevention and management of deep sternal wound infection. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):62-9. doi: 10.1053/j.semtcvs.2004.01.005.
PubMed 15366689Braxton JH, Marrin CA, McGrath PD, Morton JR, Norotsky M, Charlesworth DC, Lahey SJ, Clough R, Ross CS, Olmstead EM, O'Connor GT. 10-year follow-up of patients with and without mediastinitis. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):70-6. doi: 10.1053/j.semtcvs.2004.01.006.
PubMed 15366690Hollenbeak CS, Murphy DM, Koenig S, Woodward RS, Dunagan WC, Fraser VJ. The clinical and economic impact of deep chest surgical site infections following coronary artery bypass graft surgery. Chest. 2000 Aug;118(2):397-402. doi: 10.1378/chest.118.2.397.
PubMed 10936131Boyce JM, Potter-Bynoe G, Dziobek L. Hospital reimbursement patterns among patients with surgical wound infections following open heart surgery. Infect Control Hosp Epidemiol. 1990 Feb;11(2):89-93. doi: 10.1086/646127.
PubMed 2107250Baskett RJ, MacDougall CE, Ross DB. Is mediastinitis a preventable complication? A 10-year review. Ann Thorac Surg. 1999 Feb;67(2):462-5. doi: 10.1016/s0003-4975(98)01195-3.
PubMed 10197671Sakamoto H, Fukuda I, Oosaka M, Nakata H. Risk factors and treatment of deep sternal wound infection after cardiac operation. Ann Thorac Cardiovasc Surg. 2003 Aug;9(4):226-32.
PubMed 13129420Crabtree TD, Codd JE, Fraser VJ, Bailey MS, Olsen MA, Damiano RJ Jr. Multivariate analysis of risk factors for deep and superficial sternal infection after coronary artery bypass grafting at a tertiary care medical center. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):53-61. doi: 10.1053/j.semtcvs.2004.01.009.
PubMed 15366688Fowler VG Jr, O'Brien SM, Muhlbaier LH, Corey GR, Ferguson TB, Peterson ED. Clinical predictors of major infections after cardiac surgery. Circulation. 2005 Aug 30;112(9 Suppl):I358-65. doi: 10.1161/CIRCULATIONAHA.104.525790.
PubMed 16159846Olsen MA, Lock-Buckley P, Hopkins D, Polish LB, Sundt TM, Fraser VJ. The risk factors for deep and superficial chest surgical-site infections after coronary artery bypass graft surgery are different. J Thorac Cardiovasc Surg. 2002 Jul;124(1):136-45. doi: 10.1067/mtc.2002.122306.
PubMed 12091819Ridderstolpe L, Gill H, Granfeldt H, Ahlfeldt H, Rutberg H. Superficial and deep sternal wound complications: incidence, risk factors and mortality. Eur J Cardiothorac Surg. 2001 Dec;20(6):1168-75. doi: 10.1016/s1010-7940(01)00991-5.
PubMed 11717023Trick WE, Scheckler WE, Tokars JI, Jones KC, Reppen ML, Smith EM, Jarvis WR. Modifiable risk factors associated with deep sternal site infection after coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2000 Jan;119(1):108-14. doi: 10.1016/s0022-5223(00)70224-8.
PubMed 10612768Abboud CS, Wey SB, Baltar VT. Risk factors for mediastinitis after cardiac surgery. Ann Thorac Surg. 2004 Feb;77(2):676-83. doi: 10.1016/S0003-4975(03)01523-6.
PubMed 14759458
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00638014
- Acronym / sponsor ID
- TALON / PRO00006260
- Conditions
- Sternal Wound Infection, Mediastinitis
- Keywords
- Sternal wound closure, cardiac surgery, sternal nonunion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- KLS Martin, L.P.
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Posted 2 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Conventional wire closureConventional wires only |
| 2 | Experimental | Device: Rapid Sternal Closure SystemRapid Sternal Closure System supplemented with wires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Sternal Closure SystemSternal talons will be used and supplemented with wires | Device | 2 |
| Conventional wire closureConventional wire closure of sternum | Device | 1 |
Primary outcome
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).
1 secondary outcome
Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union
Time frame: Up to 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12573038Fry DE. The economic costs of surgical site infection. Surg Infect (Larchmt). 2002;3 Suppl 1:S37-43. doi: 10.1089/sur.2002.3.s1-37.
- Background: PubMed 16608782Friberg O, Dahlin LG, Levin LA, Magnusson A, Granfeldt H, Kallman J, Svedjeholm R. Cost effectiveness of local collagen-gentamicin as prophylaxis for sternal wound infections in different risk groups. Scand Cardiovasc J. 2006 Apr;40(2):117-25. doi: 10.1080/14017430500363024.
- Background: PubMed 2310254Demmy TL, Park SB, Liebler GA, Burkholder JA, Maher TD, Benckart DH, Magovern GJ Jr, Magovern GJ Sr. Recent experience with major sternal wound complications. Ann Thorac Surg. 1990 Mar;49(3):458-62. doi: 10.1016/0003-4975(90)90256-6.
- Background: PubMed 15366689Tang GH, Maganti M, Weisel RD, Borger MA. Prevention and management of deep sternal wound infection. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):62-9. doi: 10.1053/j.semtcvs.2004.01.005.
- Background: PubMed 15366690Braxton JH, Marrin CA, McGrath PD, Morton JR, Norotsky M, Charlesworth DC, Lahey SJ, Clough R, Ross CS, Olmstead EM, O'Connor GT. 10-year follow-up of patients with and without mediastinitis. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):70-6. doi: 10.1053/j.semtcvs.2004.01.006.
- Background: PubMed 10936131Hollenbeak CS, Murphy DM, Koenig S, Woodward RS, Dunagan WC, Fraser VJ. The clinical and economic impact of deep chest surgical site infections following coronary artery bypass graft surgery. Chest. 2000 Aug;118(2):397-402. doi: 10.1378/chest.118.2.397.
- Background: PubMed 2107250Boyce JM, Potter-Bynoe G, Dziobek L. Hospital reimbursement patterns among patients with surgical wound infections following open heart surgery. Infect Control Hosp Epidemiol. 1990 Feb;11(2):89-93. doi: 10.1086/646127.
- Background: PubMed 10197671Baskett RJ, MacDougall CE, Ross DB. Is mediastinitis a preventable complication? A 10-year review. Ann Thorac Surg. 1999 Feb;67(2):462-5. doi: 10.1016/s0003-4975(98)01195-3.
- Background: PubMed 13129420Sakamoto H, Fukuda I, Oosaka M, Nakata H. Risk factors and treatment of deep sternal wound infection after cardiac operation. Ann Thorac Cardiovasc Surg. 2003 Aug;9(4):226-32.
- Background: PubMed 15366688Crabtree TD, Codd JE, Fraser VJ, Bailey MS, Olsen MA, Damiano RJ Jr. Multivariate analysis of risk factors for deep and superficial sternal infection after coronary artery bypass grafting at a tertiary care medical center. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):53-61. doi: 10.1053/j.semtcvs.2004.01.009.
- Background: PubMed 16159846Fowler VG Jr, O'Brien SM, Muhlbaier LH, Corey GR, Ferguson TB, Peterson ED. Clinical predictors of major infections after cardiac surgery. Circulation. 2005 Aug 30;112(9 Suppl):I358-65. doi: 10.1161/CIRCULATIONAHA.104.525790.
- Background: PubMed 12091819Olsen MA, Lock-Buckley P, Hopkins D, Polish LB, Sundt TM, Fraser VJ. The risk factors for deep and superficial chest surgical-site infections after coronary artery bypass graft surgery are different. J Thorac Cardiovasc Surg. 2002 Jul;124(1):136-45. doi: 10.1067/mtc.2002.122306.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliott Bennett-Guerrero, M. D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapid Sternal Closure System and Conventional wire closure in people with Sternal Wound Infection and Mediastinitis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved (time frame: Baseline, Maximum value during postoperatively days 1 thru 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00638014, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2011.