Sternal Plating High Risk

NCT06660186 | Recruiting DMC FDA Device

• 1 other identifier: STUDY20240513
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Keywords

Cardiac Surgery; Wound Complication; Rigid Sternal Fixation; Sternal Infection; Pain; Non-union

Outcome Measures

Primary Outcomes (4)

• Sternal healing as measured by CT scan

  5 axial CT slices from a priori-defined anatomic locations are selected by a radiologist. Two additional radiologists then independently score each location using a 6-point scale (0, 1, 2, 3, 4, or 5) with higher scores representing greater healing. Sternal union will be pre-specified as a mean score ≥3 (total score ≥15).

  6 months

• Number of sternal wound complications as measured by patient/physician report

  Sternal wound complications will be a composite of wound dehiscence, sternal dehiscence, SSIs, and DSWIs (synonymous with deep SSIs and mediastinitis).

  6 months

• Total index hospitalization cost

  Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)

  6 months

• Total cost

  All costs after initial discharge through 6 months

  6 months

Secondary Outcomes (5)

• Change in pain as measured by the Wong-Baker pain scale

  Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months

• Change in prescribed narcotic use as measured by patient report

  Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months

• Change in upper extremity functional index (UEFI)

  Discharge (up to 10 days), 1 month, 6 months

• Change in quality of life as measured by the EuroQol EQ-5D-5L

  Discharge (up to 10 days), 1 month, 6 months

• Number of adverse events as measured by patient report

  Up to 6 months

Study Arms (2)

Rigid Sternal Fixation

EXPERIMENTAL

The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together.

Device: Rigid Sternal Fixation

Wire Cerclage

ACTIVE COMPARATOR

The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of the sternum together.

Device: Wire Cerclage

Interventions

Wire Cerclage DEVICE

The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of your sternum together.

Wire Cerclage

Rigid Sternal Fixation DEVICE

The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together.

Rigid Sternal Fixation

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Off-midline sternotomy
• BITA grafting
• CPB time ≥120 minutes
• Transverse sternal fracture
• Emergent or emergent salvage surgery
• Non-standard sternotomies
• Sternotomy with bony margin \<2 mm

Sponsors & Collaborators

• Stryker Nordic: collaborator
• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Pain

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Pelletier, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

• Rakesh Arora, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey Mazzurco

CONTACT

216-844-3130; Stacey.Mazzurco@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 28, 2024
• Study Start: March 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)