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Median Sternotomy clinical trials

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NCT ID: NCT05953259 Recruiting - Median Sternotomy Clinical Trials

RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy

FIXTER-2
Start date: September 27, 2023
Phase: N/A
Study type: Interventional

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 undergoing median sternotomy during cardiothoracic surgery. The main question it aims to answer is: • whether STERN FIX is a safe and efficient device to close the sternum after a sternotomy in patients of risk, achieving higher sternal stability than wires one month after surgery Participants will have their median sternotomy closed using STERN FIX in combination with wires or wires only at the end of their cardiothoracic surgery, according to the allocated treatment.

NCT ID: NCT05578651 Not yet recruiting - Median Sternotomy Clinical Trials

A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP

RACE XP
Start date: March 1, 2024
Phase:
Study type: Observational

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.

NCT ID: NCT05160298 Completed - Postoperative Pain Clinical Trials

Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery

ESB-Sterno
Start date: October 20, 2021
Phase: Phase 2
Study type: Interventional

The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. The bilateral erector spinae plane block could reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is that a single shot bilateral erector spinae plane block could reduce pain during mobilization during the first 48 hours after cardiac surgery performed with sternotomy

NCT ID: NCT01657045 Recruiting - Median Sternotomy Clinical Trials

Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy

Start date: July 2012
Phase: Phase 1
Study type: Interventional

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. Twenty-five (25) subjects receiving a median sternotomy of 16 - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be followed for 6 months post-dosing. Three cohorts of approximately 8 subjects each will be enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of needle-free dermal injections of either JVS-100 or placebo. JVS-100 or placebo will be delivered along the edge of the sternal wound using a needle-free injection device that has FDA-clearance for subcutaneous injections.

NCT ID: NCT01629030 Recruiting - Clinical trials for Coronary Artery Bypass Graft

Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

Start date: June 2012
Phase: N/A
Study type: Observational

The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.