Clinical trials: Median Sternotomy
Wound Infection
Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
The purpose of this study is to show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the…
- Trial name
- DaPro (NCT01080963)
- Testing
- Daptomycin, Cefuroxime
- Where
- Germany
- Volunteers
- 650 people
- Sponsor
- Hannover Medical School
Analgesia
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block
In 2012 Blanco et al. [1] described the ultrasound technique for Pectoral nerve (PECS) block as a new, less invasive regional analgesic technique for breast surgeries.
- Trial name
- NCT06636578
- Testing
- dexmedetomidine, ropivacaine, fentanyl
- Where
- 2 sites in Egypt
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Fayoum University
Postoperative Pulmonary Complications (PPCs), Cardiac Surgery With Sternotomy
Effect of Positioning and ACBT on Pulmonary Complications After Cardiac Surgery
The goal of this quasi-experimental clinical trial is to learn if position management combined with the Active Cycle of Breathing Techniques (ACBT) works to reduce postoperative pulmonary complications in adult patients…
- Conditions
- Postoperative Pulmonary Complications (PPCs), Cardiac Surgery With Sternotomy, Atelectasis, Postoperative Pneumonia
- Trial name
- P-ACBT (NCT07612033)
- Testing
- Structured Position Management Protocol, Active Cycle of Breathing Techniques (ACBT)
- Where
- Egypt
- Volunteers
- 124 people
- Sponsor
- Assiut University
Cardiac Conditions
Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
The purpose of the study is to determine the plasma concentration of bupivacaine at various time points after Exparel (bupivacaine liposome injectable suspension, Pacira Pharmaceuticals, Inc., Parsippany, NJ) is injected…
- Trial name
- CohortI-II (NCT04685421)
- Testing
- Bupivacaine liposome
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Postoperative Pain Management, Open-heart Surgery
Erector Spinae Plane Block and Postoperative Recovery After Open-Heart Surgery
This prospective randomized controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median…
- Conditions
- Postoperative Pain Management, Open-heart Surgery, Median Sternotomy, Erector Spinae Plane Block
- Trial name
- ESPB-SYSHEART (NCT07259057)
- Testing
- Erector spinae plane block (ESPB), Intravenous Opioid Analgesia
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Karadeniz Technical University
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
Post Operative Pain
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT
The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent…
- Trial name
- NCT05642416
- Testing
- Continuous Infusion of ropivacaine, Intermittent bolus of ropivacaine
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Henry Ford Health System
Complete Vertical Midline Sternotomy / Cardiac Surgery
Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing
Mediastinitis is the most feared infectious complication after cardiac surgery. Several risk factors are known such as: obesity, diabetes, chronic obstructive pulmonary disease, double breast sampling, immunodeficiency…
- Trial name
- PRISTER (NCT06207630)
- Testing
- Dressing Device
- Where
- 5 sites in France
- Volunteers
- 660 people
- Sponsor
- Poitiers University Hospital
Cardiovascular Surgical Procedures, Pain, Postoperative
Fascial Plane Blocks and Quality of Recovery in Cardiac Surgery
In this randomized trial, the investigators will test the hypothesis that combining regional analgesia techniques-which have the potential to improve the quality of postoperative recovery following median sternotomy-with PIFB…
- Conditions
- Cardiovascular Surgical Procedures, Pain, Postoperative, Cardiovascular Diseases
- Trial name
- NCT07557108
- Testing
- Ultrasound-Guided Pectointercostal Fascial Plane Block, Ultrasound-Guided Rectus Sheath Block, Ultrasound-Guided Recto-Intercostal Fascial Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 123 people
- Sponsor
- Ordu University
Cardiac Surgery
Bilateral Erector Spinae Plane Block for Management of Acute Postoperative Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy
Many analgesic modalities have been investigated in pediatrics. The analgesic efficacy of bilateral ultrasound-guided erector spinae plane block in pediatric patients undergoing open midline sternotomy will be examined.
- Trial name
- NCT05142176
- Testing
- Erector spinae catheters insertion, Postoperative pain management
- Volunteers
- 75 people
- Sponsor
- Tanta University
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
Congenital Heart Disease
Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy
The serratus anterior plane block (SAPB) is an anterolateral thoracic wall block that was described in 2013 by Blanco et al. who presented it as an alternative to other regional anesthetic techniques.
- Trial name
- NCT06221150
- Testing
- Bilateral two level serratus anterior block
- Where
- Egypt
- Volunteers
- 48 people
- Sponsor
- Cairo University
Cardiac Surgery
A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients undergoing cardiac surgery to see if it will be…
- Trial name
- NCT00586976
- Testing
- Ropivacaine, Normal saline
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Mayo Clinic
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
Median Sternotomy, Pain Management
Effect of Parasternal Plane Block on Intraoperative Nociception
Effective pain control during pediatric cardiac surgery remains a major clinical challenge, particularly in procedures involving median sternotomy, which is associated with intense nociceptive stimulation.
- Trial name
- NCT07354750
- Testing
- Parasternal Plane Block, Group without peripheral nerve block
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
Coronary Artery Disease, Valve Disease, Heart
Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting
The purpose of this study is to determine if performed force measurements yield a different recommended weight lifted during the sternotomy healing process than the traditional gold standard of 5 pounds.
- Trial name
- NCT05924568
- Testing
- Educational session with Keep Your Move in the Tube and PrimusRS
- Sponsor
- Brandon Hathorn
Valvular Heart Disease
Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery
PURPOSE: The aim of this study is to investigate the effect of trunk stabilizing exercises on sternal instability in patients with median sternotomy after heart valve surgery
- Trial name
- SIS (NCT04632914)
- Testing
- trunk stabilizing exercise, cardiac rehabilitation programe
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Cairo University
Cardiac Surgery, Median Sternotomy
Early Rehabilitation in Patients Following Major Cardiac Surgery: Changes in Functional Capacity and Energy Efficiency in Walking and ADLs.
The main objective of this clinical trial is to evaluate exercise capacity before and after an inpatient or outpatient rehabilitation program in patients following major cardiac surgery.
- Trial name
- K5-POSTCCH (NCT07843316)
- Testing
- Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities.
- Where
- 3 sites in Italy
- Volunteers
- 60 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA