Clinical trials: Sternal Closure
Wound Complication, Cardiac Surgery
Effectiveness of Topical Vancomycin in Reducing Sternal Wound Infections Post-Cardiac Surgery
Title: The Role of Vancomycin Powder in Reducing Sternal Wound Infections Following Cardiac Surgery: A Randomized Controlled Trial Introduction: Sternal wound infections (SWIs) are significant complications in cardiac surgery…
- Trial name
- NCT06651268
- Testing
- while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T
- Where
- Pakistan
- Volunteers
- 24 people
- Sponsor
- Liaquat National Hospital & Medical College
Sternal Wound Infection, Mediastinitis
Rapid Sternal Closure System (TALON)
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.
- Trial name
- TALON (NCT00638014)
- Testing
- Rapid Sternal Closure System, Conventional wire closure
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Duke University
Sternotomy
Sternal Fixation With STERN FIX After Medial Sternotomy
The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.
- Trial name
- NCT05784532
- Testing
- STERN FIX
- Where
- United States
- Sponsor
- NEOS Surgery
Cardiovascular Disease, Surgical Site Infection
Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients
The goal of this clinical trial is to learn if a new method of closing the breastbone after heart bypass surgery can improve healing and reduce complications in adults undergoing coronary artery bypass graft (CABG) surgery.
- Conditions
- Cardiovascular Disease, Surgical Site Infection, Superficial Sternal Wound Infection, Mediastinitis
- Trial name
- NCT07507409
- Testing
- Knotless Barbed Sutures, Mesh-based Topical Skin Adhesive
- Volunteers
- 401 people
- Sponsor
- Unity Health Toronto
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.
Post Cardiac Surgery, Sternal Closure
TORQ Clinical Study
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
- Trial name
- TORQClin (NCT01647178)
- Testing
- TORQ assisted sternal closure, Conventional closure
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Kardium Inc.
Hypoplastic Left Heart Syndrome
Positive Pressure Ventilation and Sternal Closure in HLHS
This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure.
- Trial name
- NCT02455713
- Testing
- PEEP and PIP
- Where
- Canada
- Sponsor
- The Hospital for Sick Children
Coronary Artery Disease
Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery
Kryptonite is a non-toxic biologic polymer, that has previously been used in orthopedic surgery. The objective of our study is to demonstrate the benefits of Kryptonite in cardiac surgery patients at high risk for sternal wound…
- Trial name
- Kryptonite (NCT01368991)
- Testing
- Kryptonite, Conventional closure
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Cardiology Research UBC
Lung, Lung Transplant
Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant
This will be a prospective, randomized clinical trial, comparing the sternal alignment between the fixation with rigid plate X steel wires.
- Trial name
- LungTx-Lock (NCT05055739)
- Testing
- Rigid plate X steel wires
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- University of Sao Paulo General Hospital
Sternotomy Closure,Open Heart Surgery
Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective.
- Trial name
- FIX IT ALL (NCT07366203)
- Testing
- SC03 Plating system, Stainless steel wires
- Volunteers
- 190 people
- Sponsor
- NEOS Surgery
Sternal Closure
Sternal Closure With Biologic Bone Cement in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG) in patients undergoing surgery for coronary artery disease.
- Trial name
- NCT01261858
- Testing
- Kryptonite
- Where
- Singapore
- Volunteers
- 64 people
- Sponsor
- National University Heart Centre, Singapore
Cardiac Surgery, Sternal Closure
Sternalock Versus Wires for Sternal Closure Study
Design: Investigator Initiated Prospective Randomised Trial Study Centre's: Melbourne Private Hospital Royal Melbourne Hospital Study Hypothesis: Use of the SternaLock 360 will reduce the incidence of sternal motion > 2mm by…
- Trial name
- NCT03282578
- Testing
- Sternalock 360 sternal plating system, Sternal Wires
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- University of Melbourne
Palliation of Congenital Heart Diseases, Cardiopulmonary Bypass
Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure
This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.
- Conditions
- Palliation of Congenital Heart Diseases, Cardiopulmonary Bypass, Chest Wall Mechanics, Neonatal Delayed Sternal Closure
- Trial name
- NCT05257525
- Testing
- Esophageal manometry catheter at various PEEP levels and tidal volumes
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- The Hospital for Sick Children
Open Heart Surgery
Sternal Closure in Children After Cardiac Surgery
comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection \& cosmetic outcome
- Trial name
- NCT05715060
- Testing
- Median sternotomy closure (sternal closure)
- Where
- Egypt
- Volunteers
- 45 people
- Sponsor
- Assiut University
Sternum Wound Infection, Nonunion of Fracture of Sternum
Sternal Closure With STERNUMFIX in Patients With High Risk
The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound…
- Trial name
- STEPHIX (NCT01408745)
- Testing
- Sternumfix, steel wire
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 166 people
- Sponsor
- Aesculap AG
Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2)
Sternal Closure in High-BMI Patients: Cable vs Wire
This retrospective study compares two sternal closure techniques-standard stainless-steel wires and rigid cable systems-in adult patients with a body mass index (BMI) ≥30 who underwent open-heart surgery between January 1, 2020…
- Conditions
- Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2), Median Sternotomy, Cardiac Surgery
- Trial name
- NCT07097272
- Where
- Turkey (Türkiye)
- Volunteers
- 110 people
- Sponsor
- Samsun University
Sternal Closure
Montage-Enhanced Sternal Closure
Post-operative recovery after cardiac surgery is influenced by early sternal bone stability. Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless steel wires.
- Trial name
- NCT03365843
- Testing
- Montage bone putty, Conventional Sternal Closure
- Where
- Canada
- Volunteers
- 65 people
- Sponsor
- University of Calgary
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
Pain
A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method is better than the other.
- Trial name
- NCT01317095
- Testing
- Sternalock Rigid Fixation
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Thomas Jefferson University