A Phase 4 interventional study of Rapid Sternal Closure System and Conventional wire closure in Sternal Wound Infection and Mediastinitis, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-02.
Sponsored by Duke University · Phase 4, Interventional, and Prevention
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.
21 studies on the registry are indexed under Mediastinitis; 3 are open to participants now.
This study's enrollment of 51 is below the median of 83 across 12 interventional studies indexed under Mediastinitis.
Browse Mediastinitis studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conventional wires only
Device: Conventional wire closure
Rapid Sternal Closure System supplemented with wires
Device: Rapid Sternal Closure System
Sternal talons will be used and supplemented with wires
Conventional wire closure of sternum
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).
Time frame: Baseline, Maximum value during postoperatively days 1 thru 7
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.
Time frame: Up to 180 days
Subjects were consented and enrolled in the study at 2 centers from April 2008 to July 2009.
| Milestone | Conventional Wires Only | Talon |
|---|---|---|
| Started | 23 | 28 |
| Completed | 23 | 28 |
| Not completed | 0 | 0 |
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).
| percentage change | Conventional Wires Only | Talon |
|---|---|---|
| Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved | 58 ± 24 | 67 ± 32 |
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.
| Participants | Conventional Wires Only | Talon |
|---|---|---|
| Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union | 1 | 1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Wires Only | — | 1/23 (4.3%) | 0/23 (0%) |
| Talon | — | 1/28 (3.6%) | 0/28 (0%) |
| Event | Conventional Wires Only | Talon |
|---|---|---|
| Renal failureRenal and urinary disorders | 1/23 | 0/28 |
| Chest tube entrapment between sternal halves (not Talon)Surgical and medical procedures | 0/23 | 1/28 |
| Age, Categorical(Participants) | Conventional Wires Only | Talon | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 16 | 30 |
| >=65 years | 9 | 12 | 21 |
| Age Continuous(years) | Conventional Wires Only | Talon | Total |
|---|---|---|---|
| Mean | 63.0 ± 9.2 | 61.8 ± 10.0 | 62.4 ± 9.6 |
| Sex: Female, Male(Participants) | Conventional Wires Only | Talon | Total |
|---|---|---|---|
| Female | 9 | 4 | 13 |
| Male | 14 | 24 | 38 |
| Region of Enrollment(participants) | Conventional Wires Only | Talon | Total |
|---|---|---|---|
| United States | 23 | 28 | 51 |
The record gives a start of Mar 2008, a primary completion of Jul 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.
Results were first posted in May 2011, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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