Clinical trials: Median Sternotomy
Coronary Artery Disease, Angina Pectoris
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Cardiac Valve Disease
- Trial name
- SB (NCT01783483)
- Testing
- SternaLock Blue closure system, Suture Wire
- Where
- 12 sites in United States
- Volunteers
- 236 people
- Sponsor
- Zimmer Biomet
Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass.
- Conditions
- Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass, Sternotomy
- Trial name
- NCT00161733
- Testing
- Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D), TISSEEL VH fibrin sealant
- Where
- 22 sites in United States
- Sponsor
- Baxter Healthcare Corporation
Rigid Plate Fixation, Median Sternotomy
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
- Trial name
- RACE XP (NCT05578651)
- Testing
- SternaLock XP
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Surgical Wound Infection
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized…
- Trial name
- NCT00203541
- Testing
- TELFA™ A.M.D. Island dressing
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- Tyco Healthcare Group
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Median Sternotomy
Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
This study will investigate the safety and efficacy of using JVS-100 to accelerate wound healing and reduce scar formation in subjects receiving surgical incisions ("sternotomies") during cardiovascular surgery.
- Trial name
- NCT01657045
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- SironRX Therapeutics, Inc.
Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection
Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier.
- Trial name
- NBCS (NCT06869772)
- Testing
- Closure of sternotomy
- Where
- Qatar
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
Advanced Refractory Left Ventricular Heart Failure
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS).
- Trial name
- SWIFT (NCT04548128)
- Testing
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Where
- 32 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
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.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
Pain
A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery
The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery
- Trial name
- NCT00636064
- Testing
- Parecoxib Sodium/Valdecoxib
- Where
- 206 sites in United States, Argentina and 25 more
- Volunteers
- 1,671 people
- Sponsor
- Pfizer
Surgical Site Occurences After Sternotomy, Wound Infection
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy).
- Trial name
- NCT02195310
- Testing
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Where
- 13 sites in Austria, Germany and 1 more
- Volunteers
- 342 people
- Sponsor
- Solventum US LLC
Post Operative Pain, Midline Sternotomy Incision
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery
- Trial name
- POPS (NCT03750357)
- Testing
- Primary Relief v 2.0
- Where
- India
- Volunteers
- 60 people
- Sponsor
- DyAnsys, Inc.
Median Sternotomy
RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy
The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk…
- Trial name
- FIXTER-2 (NCT05953259)
- Testing
- Combination of STERN FIX and wires, Wires
- Where
- 5 sites in Germany, Spain
- Volunteers
- 90 people
- Sponsor
- NEOS Surgery
Retrospective Review, Cerclage
Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy
This is a retrospective study based on analysis real world data obtained from hospitals that have adopted use of Montage or Montage-CT for use following sternotomy.
- Conditions
- Retrospective Review, Cerclage, Pain Management
- Trial name
- NCT07215546
- Testing
- Montage or Montage CT
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Abyrx, Inc.