Low Thermal Electrosurgical Device for Atraumatic Internal Thoracic Artery Harvesting

NCT03510026 | Completed

• 1 other identifier: KEK-ZH-Nr. 2013-0017
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Electrosurgery is fundamental to the precise, fast and bloodless preparation of internal thoracic artery grafts in cardiac surgery. The PEAK PlasmaBlade is a monopolar electrosurgical device that uses pulsed radiofrequency energy to generate a plasma-mediated discharge along an insulated electrode, creating a cutting edge while the blade stays near body temperature. The aim of this study is to compare the histological samples, cardiac computed-tomography of graft patency, and clinical outcomes of patients after off-pump coronary artery bypass grafting with preparation of the internal thoracic arteries by a conventional electrosurgical device and the PlasmaBlade.

Conditions

Preparation of Internal Thoracic Artery

Keywords

internal thoracic artery harvesting; arterial graft patency; electrosurgery; arterial graft preparation

Outcome Measures

Primary Outcomes (1)

• Endothelial damage

  Histological examination of internal thoracic artery samples stained for endothelial damage.

  six months

Secondary Outcomes (2)

• Vessel wall integrity

  six months

• Patency of internal thoracic arteries as bypass grafts

  six months

Study Arms (1)

Low thermal device preparation

OTHER

One participant acts simultaneously as a control and active comparator. One internal thoracic artery is prepared with the normal electrocautery device. The other internal thoracic artery is prepared with the new low thermal device. The participant does not know, which internal thoracic artery is defined to be prepared with the low thermal device.

Device: Low thermal device preparation

Interventions

Low thermal device preparation DEVICE

One participant acts simultaneously as a control and active comparator. One internal thoracic artery is prepared with the normal electrocautery device. The other internal thoracic artery is prepared with the new low thermal device. The participant does not know, which internal thoracic artery is defined to be prepared with the low thermal device.

Low thermal device preparation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients receiving elective coronary artery bypass grafting with both internal thoracic arteries
• signed consent

You may not qualify if:

• emergency procedures
• patients, who are already involved in other studies
• pregnant women or women of childbearing Age
• missing signed consent

Sponsors & Collaborators

• Triemli Hospital: lead

Related Publications (1)

• Zientara A, Komminoth P, Seifert B, Odavic D, Dzemali O, Haussler A, Genoni M. Skeletonized internal thoracic artery harvesting: a low thermal damage electrosurgical device provides improved endothelial layer and tendency to better integrity of the vessel wall compared to conventional electrosurgery. J Cardiothorac Surg. 2018 Oct 11;13(1):105. doi: 10.1186/s13019-018-0797-3.

  PMID: 30305183 DERIVED

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 27, 2018
• Study Start: August 8, 2013
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 27, 2018

Record last verified: 2018-04