Clinical trial NCT06660186: Sternal Plating High Risk
Official title: Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Diseases
Keywords: Cardiac Surgery
Wound Complication
Rigid Sternal Fixation
Sternal Infection
Pain
Non-union
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2024-10-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.


Eligibility criteria: Preoperative Inclusion Criteria

* Adults (age range: 18-89)
* Undergoing cardiac surgery through sternotomy

  -≥2 risk factors:
* Diabetes mellitus
* Severe COPD
* Chronic steroid use
* Immunosuppression
* Redo sternotomy
* Chronic
* Kidney disease with GFR \>30 ml/min per 1.73m2
* Radiation therapy
* BMI≥35
* High-risk of delirium
* Heavy alcohol use

Preoperative Exclusion Criteria

* Active malignancy
* Chronic narcotic use
* NYHA Class IV
* Known nickel metal allergy
* Compliance concern
* eGFR\<30 ml/min per 1.73m2
* Involvement in another interventional clinical trial (non-registry)
* Any criteria precluding RPF or WC

Operative Inclusion Criteria

* Off-midline sternotomy
* BITA grafting
* CPB time ≥120 minutes
* Transverse sternal fracture

Operative Exclusion Criteria

* Emergent or emergent salvage surgery
* Non-standard sternotomies
* Sternotomy with bony margin \<2 mm
* Bleeding
* Delayed sternal closure
* Surgical complications
* Any criteria precluding RPF or WC

Primary outcomes:
measure: Sternal healing as measured by CT scan
timeFrame: 6 months
measure: Number of sternal wound complications as measured by patient/physician report
timeFrame: 6 months
measure: Total index hospitalization cost
timeFrame: 6 months
measure: Total cost
timeFrame: 6 months
Secondary outcomes:
measure: Change in pain as measured by the Wong-Baker pain scale
timeFrame: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months
measure: Change in prescribed narcotic use as measured by patient report
timeFrame: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months
measure: Change in upper extremity functional index (UEFI)
timeFrame: Discharge (up to 10 days), 1 month, 6 months
measure: Change in quality of life as measured by the EuroQol EQ-5D-5L
timeFrame: Discharge (up to 10 days), 1 month, 6 months
measure: Number of adverse events as measured by patient report
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals
name: Marc Pelletier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals
name: Rakesh Arora, MD
role: PRINCIPAL_INVESTIGATOR
References: