Sternal Wound InfectionRESTORENCT00819286

Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

A study testing SternaLock Rigid Fixation Plates in people with Sternal Wound Infection and Sternal Non-union, run by Zimmer Biomet at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sternal Wound Infection, Sternal Non-union, Pain
What is being tested?: SternaLock Rigid Fixation Plates
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 6 sitesin 2 countries
Study dates: Nov 2008to Dec 2011
Phase: Interventional
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

Patients undergoing median sternotomy;
Patients eighteen (18) years of age or older;
Patients presenting two or more risk factors such as diabetes mellitus, Chronic Obstructive Pulmonary Disease, obesity (BMI > 30), osteoporosis, Renal failure, Chronic steroid use, Immunosuppression, Redo sternotomy, Neurologic dysfunction severely affecting ambulation,
Off mid-line sternotomy
bilateral IMA use
Long cardio-pulmonary bypass runs
Transverse fractures of the sternum

Who cannot join

Patients with a non-standard sternotomy;
Patients with an off-midline sternotomy that reduced the bony margin to <2mm
Patients under eighteen (18) years of age;
Patients that are pregnant or currently lactating;
Patients presenting intra-operative conditions that would require the use of rigid fixation and/or additional post-sternotomy mechanical support beyond wire cerclage due to surgical evaluation,
Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure,

Show all 11Show fewer

Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia;
Patients undergoing post-operative revision procedures that treat the original sternotomy in such a way as to affect outcome (antibiotic irrigation, debridement or other treatment to the osteotomy);
Patients unwilling or unable to return for follow-up;
Lacking the ability to follow instructions;
Intraoperative death.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States5 sites

University of Chicago
Chicago, Illinois, 60637
Baptist Memorial Hospital
Memphis, Tennessee, 38120
St. Joseph's Heart and Lung Institute
Phoenix, Arizona, 85013
University of California Davis Medical Center
Sacramento, California, 95817
Scott & White Memorial Hospital
Temple, Texas, 76508

Other trials in United States

Germany1 site

Leipzig Heart Center
Leipzig

Other trials in Germany

About this study

Official title: A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain

Read the detailed description

Median sternotomy patients will be randomized to either wire or rigid fixation groups. A scheduled evaluation period will record clinical parameters. Enrollment has ended with one hundred forty (140) patients.

Conditions: Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
Being tested: SternaLock Rigid Fixation Plates, wire (control)
Keywords: open heart surgery
Medical subject headings: Pain, Mediastinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SternaLock Rigid Fixation PlatesDevice
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
wire (control)Device
patients will have their sternum closed using wire (stainless steel surgical wire).

Study groups in NCT00819286
Study group	Role	What they receive
wire (control)	Active comparator	patients will have their sternum closed using wire (stainless steel surgical wire). Receives: Device: wire (control)
SternaLock Rigid Fixation Plates	Experimental	patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates. Receives: Device: SternaLock Rigid Fixation Plates

What is being measured

The primary outcome is the main question the study is designed to answer.

CT Scan Evaluation of Sternal Bone Healing
Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)
Measured: 3 and 6 Months
Activity Based Total Visual Analog Pain Score
Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an "Activity Based Total Visual Analog Pain Score", (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Dec 2011

First posted8 Jan 2009 (estimated)
Study startNov 2008
Primary completionJan 2011
Study completionDec 2011

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.
Other trials for Sternal Wound InfectionStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00819286
Sponsor's protocol ID: 07071
Acronym: RESTORE
Status last verified: Jan 2018
First submitted: 6 Jan 2009
Last updated: 13 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Sternal Plating High Risk
Heart Diseases
Not yet recruitingPhase 4
Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients
Cardiovascular Disease, Surgical Site Infection
Active, not recruitingObservational study
The Role of Inflammatory Biomarkers in Preventing Deep Sternal Wound Infections After Sternotomy
Deep Sternal Infection, Diabete Mellitus
Not yet recruitingObservational study
Risk Factors for Deep Sternal Wound Infection After Coronary Artery Bypass Grafting
Coronary Artery Bypass Grafting
Recruiting
Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Wound of Skin

All Sternal Wound Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain
ClinicalTrials.gov ID: NCT00819286
Acronym / sponsor ID: RESTORE / 07071
Conditions: Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
Keywords: open heart surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jan 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 8 Jan 2009 (estimated)
Results: Posted 15 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
wire (control)	Active comparator	Device: wire (control)patients will have their sternum closed using wire (stainless steel surgical wire).
SternaLock Rigid Fixation Plates	Experimental	Device: SternaLock Rigid Fixation Platespatients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients undergoing median sternotomy;
Patients eighteen (18) years of age or older;
Patients presenting two or more risk factors such as diabetes mellitus, Chronic Obstructive Pulmonary Disease, obesity (BMI > 30), osteoporosis, Renal failure, Chronic steroid use, Immunosuppression, Redo sternotomy, Neurologic dysfunction severely affecting ambulation,
Off mid-line sternotomy
bilateral IMA use

Key exclusion criteria (11 listed)

Patients with a non-standard sternotomy;
Patients with an off-midline sternotomy that reduced the bony margin to <2mm
Patients under eighteen (18) years of age;
Patients that are pregnant or currently lactating;
Patients presenting intra-operative conditions that would require the use of rigid fixation and/or additional post-sternotomy mechanical support beyond wire cerclage due to surgical evaluation,

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
SternaLock Rigid Fixation Platespatients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates	Device	SternaLock Rigid Fixation Plates
wire (control)patients will have their sternum closed using wire (stainless steel surgical wire).	Device	wire (control)

Primary outcome

CT Scan Evaluation of Sternal Bone Healing
Time frame: 3 and 6 Months
Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)
Activity Based Total Visual Analog Pain Score
Time frame: 6 months
Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an "Activity Based Total Visual Analog Pain Score", (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated.

Results and safety

Results posted to the registry on 15 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wire (Control)	70	56
Plates	70	45

Primary outcome: CT Scan Evaluation of Sternal Bone Healing

Time frame: 3 and 6 Months. Mean (Standard Deviation). Unit: units on a scale

Measure	Wire (Control) n = 48	Plates n = 46
3 Month CT Scan (n=25 wire, n=27 plates)	0.9 (0.8)	1.7 (1.1)
6 Month CT Scan (n=26 wire, n=23 plates)	2.2 (1.1)	3.2 (1.6)

Wire (Control) vs Plates: Mean Difference (Final Values): 0, p = 0.003, t-test, 2 sided
Wire (Control) vs Plates: p = 0.01, t-test, 2 sided

Population analysed: Patients were randomized to receive a CT scan at either 3 or 6 months. All patients who received a CT scan were included in the analysis.

Primary outcome: Activity Based Total Visual Analog Pain Score

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Wire (Control) n = 56	Plates n = 44
Value	7.28 (4.65)	7.20 (4.04)

Wire (Control) vs Plates: Mean Difference (Final Values): 0, p = 0.93, t-test, 1 sided

Population analysed: All patients with VAS pain data at 6 months were included in the analysis of the primary endpoint Activity Based Total Visual Analog Pain Score.

Adverse events

Time frame: 0 to 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wire (Control)	24 of 70 (34.3%)	20 of 70 (28.6%)	Not reported
Plates	32 of 70 (45.7%)	24 of 70 (34.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sternal Wound Infection

Recruiting
Sternal Plating High Risk
Heart Diseases
Not yet recruitingPhase 4
Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients
Cardiovascular Disease, Surgical Site Infection
Active, not recruitingObservational study
The Role of Inflammatory Biomarkers in Preventing Deep Sternal Wound Infections After Sternotomy
Deep Sternal Infection, Diabete Mellitus
Not yet recruitingObservational study
Risk Factors for Deep Sternal Wound Infection After Coronary Artery Bypass Grafting
Coronary Artery Bypass Grafting
Recruiting
Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Wound of Skin

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.

Jai Raman, MD study chair

University of Chicago

Michael Wong, MD principal investigator

University of California Davis Medical Center, Sacramento, CA

Brian DeGuzmann, MD principal investigator

St. Joseph's Medical Center, Phoenix, AZ

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SternaLock Rigid Fixation Plates in people with Sternal Wound Infection and Sternal Non-union, run by Zimmer Biomet at 6 sites in 2 countries.

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 7 inclusion and 11 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Germany. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2012). 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?

CT Scan Evaluation of Sternal Bone Healing (time frame: 3 and 6 Months). The study lists 2 primary outcomes in all. 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 NCT00819286.

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 13 Feb 2018.