Clinical Trials Logo
  1. Home
  2. Sternotomy
  3. NCT04743895

Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone

Sternotomy Clinical Trial

Official title:
Randomized, Single Blinded Pilot Study of Stainless Steel Wire Cerclage Versus FiberTape® Cerclage

Clinical Trial Summary

This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.

Clinical Trial Description

The primary objective of this study is to evaluate the progression of sternal healing in subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire. The secondary objectives are to evaluate the complication rate and postoperative pain of subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire. CT scans are performed at three months postoperatively to assess sternal healing. Two radiologists will read all CT scans. Axial slices are analyzed at five locations along the sternum (manubrium, top of the aortic arch, aortopulmonary window, main pulmonary arteries, and aortic root) using a 6-point quantitative scale (0=no sign of healing, 1=minimal healing, 2=mild healing, 3=moderate healing, 4=partial synthesis, 5=complete synthesis). All adverse events related to the sternal closure procedure or the devices used for closure will be collected. Postoperative pain scores will be collected using a 10 cm visual analog scale (VAS) with a numeric rating of 0 to 10. Sternal pain will be rated at rest, coughing, and with movement. Postoperative analgesic use for sternal closure pain will be evaluated.The Veterans Rand (VR-12) health survey will be collected postoperatively (see schedule of events for details). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04743895
Study type Interventional
Source Arthrex, Inc.
Contact
Status Completed
Phase N/A
Start date January 4, 2021
Completion date May 6, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT00976313 - Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery? N/A
Completed NCT00161733 - 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 Phase 3
Completed NCT06153550 - The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery
Completed NCT04626180 - EFFECT OF PRE EXTUBATION MANUAL HYPERINFLATION TECHNIQUE VS REGULAR EXTUBATION AFTER STERNOTOMY N/A
Completed NCT02457572 - Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition N/A
Completed NCT04591119 - Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery N/A
Recruiting NCT04585867 - Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy Phase 1
Recruiting NCT06115759 - RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy N/A
Completed NCT05676814 - Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients Phase 4
Recruiting NCT06418100 - Recto-intercostal Block for Coronary Artery Bypass Grafting N/A
Completed NCT01870063 - Comparision of FIBTEM and Blood-loss N/A
Recruiting NCT04985500 - ESP/PIF for Sternotomy Early Phase 1
Completed NCT05356715 - Erector Spinae Plane Block in Post-operative Recovery in Cardiac Surgery With Median Sternotomy. N/A
Completed NCT02031016 - Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain Phase 4
Not yet recruiting NCT00822419 - Percutaneous Ketamine Versus Lidocaine for Mid-Sternotomy Phase 4
Completed NCT04593732 - STERN FIX Device as a Sternal Fixation System N/A
Completed NCT01828788 - Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters Phase 2
Recruiting NCT05357963 - Incidence of Chronic Pain After Sternotomy
Recruiting NCT05784532 - Sternal Fixation With STERN FIX After Medial Sternotomy