Trial document




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  DRKS00006182

Trial Description

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Title

Peak Plasma Blade in comparison with electro cauterisation during aggregate replacement of implantable cardioverter defibrillators

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In the proposed study , two different electrosurgical cutting- and coagulationinstruments , are compared in terms of effectiveness and safety in aggregate replacement interventions of implantable cardioverter defibrillators. The study hypothesis is a possible benefit of the Peak Plasma Blade cauterisation concerning procedural duration and possible procedure related complications. This hypothesis is based on the assumption that the PeakPlasma blade enables a quicker intraoperative proceeding due to a diminished heating of device leads and surrounding tissue.
Implantable cardioverter defibrillators are a cornerstone for the therapy of life threatening cardiac arrhythmias. However, these devices have limited battery life, this circumstance requires aggregate replacement surgeries during the course of treatment.
Alltogether 80 patients are intended to be included into this study. Patients will be divided into two study groups of 40 patients each, which will be randomised to standard electrocauterisation or PlasmaBlade cauterisation. There are both women and men who are older than 18 years and have a planned aggregate replacement right included.

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Brief Summary in Scientific Language

Study object

Object of this study the operative aggregate replacement in patients with implanted cardioverter defibrillators.

Study aim

Aim of this study is the comparison of two electro surgical instruments concerning efficacy and safety during surgical interventions for aggregate replacement.

Background

Implantable cardioverter defibrillators are a cornerstone for the therapy of life threatening cardiac arrhythmias.4 One of the characteristics of the implanted aggregates is a limited battery life of certain years. This circumstance requires aggregate replacement surgeries during the course of treatment.4
For the operative aggregate replacement a surgical preparation of the aggregate and the proximal lead parts is performed. Especially the proximal lead portions often adhere densely with the fibrotic aggregate pocket, which necessitates a careful procedure to avoid lead injuries. So far these surgeries are performed with the aid of electro surgical cauterisation which enables a precise incision as well as blood coagulation. Electro cauterisation is based on radiofrequency current in the form of continuous wavelets. Cutting and coagulation with standard electro cauterisation causes a relevant heating of surrounding structures.3 The so called Peak Plasmablade™ presents a possible alternative electro surgical instrument, which works with pulsed plasma mediated electrical current application. This technique enables surgical cutting and coagulation at significantly lower temperatures compared to conventional cauterisation.2,3 In the context of experimental comparative studies incisions with the Peak Plasmablade showed reduced thermal injury depth, reduced inflammation response and better scar healing compared to standard electro cauteristation.1
Up to now no study evaluating benefits and complications of Peak Plasma Blade in comparison to the standard electro cauterisation during aggregate replacement sugery has been performed yet.

Hypothesis

Study hypothesis is a possible benefit of the Peak Plasma Blade cauterisation concerning procedural duration and possible procedure related complications. This hypothesis is based on the assumption that the PeakPlasma blade enables a quicker intraoperative proceeding due to a diminished heating of device leads and surrounding tissue.

Study Design

This is a prospective, single blinded, randomised interventional study

Endpoints

Primary endpoint:
• Surgical preparation duration (from skin incision to aggregate exposure)
Secundary endpoints:
• Total procedure duration (from skin incision to skin suture)
• Changes in electrical lead values (pacing threshold, impedance, sensing)
• Lead isolation injuries
• Wound infections
• Aggregate pocket hematoma
• Wound healing deficits

Sample size:

Alltogether 80 patients are intended to be included into this study. Patients will be divided into two study groups of 40 patients each, which will be randomised to standard electrocauterisation or PlasmaBlade cauterisation.





References:

1. Ruidiaz ME, Messmer D, Atmodjo DY, et al. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111.
2. Loh SA, Carlson GA, Chang EI, Huang E, Palanker D, Gurtner GC. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg. 2009;124(6):1849-1859.
3. Chang EI, Carlson GA, Vose JG, Huang EJ, Yang GP. Comparative healing of rat fascia following incision with three surgical instruments. J Surg Res. 2011;167(1):47-54.
4. European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA), Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE. , 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA)., Europace. 2013 Aug;15(8):1070-118. doi: 10.1093/europace/eut206. Epub 2013 Jun 24.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006182
  •   2014/05/26
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  •   yes
  •   Approved
  •   EA2/170/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   I50 -  Heart failure
  •   planned aggregate replacement of implantable cardioverter defibrillators
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Interventions/Observational Groups

  •   Aggregate replacement operations of implantable cardioverter defibrillators by Peak PlasmaBlade
  •   Aggregate replacement operations of implantable cardioverter defibrillators by electro cauterisation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Surgical preparation duration (from skin incision to aggregate exposure)

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Secondary Outcome

- Total procedure duration (from skin incision to skin suture)
- Changes in electrical lead values (pacing threshold, impedance, sensing)
- Lead isolation injuries
- Wound infections
- Aggregate pocket hematoma
- Wound healing deficits

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/05/26
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Planned aggregate replacement of an implanted cardiac defibrillator
- Patient age ≥ 18 years
- Presence of an oral and written patient informed consent

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Exclusion Criteria

- Patients with a primary indication for the application of one of the two investigated surgical instruments
- Pregnancy
- Patients who stand under legal or medical supervision
- Participation in another interventional study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Klinik m.S. KardiologieCharité Campus Virchow Klinikum
    • Mr.  Dr. med. univ.  Martin  Huemer 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Medizinische Klinik m.S. KardiologieCharité Campus Virchow Klinikum
    • Mr.  Dr. med. univ.  Martin  Huemer 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Medizinische Klinik m.S. KardiologieCharité Campus Virchow Klinikum
    • Mr.  Dr. med. univ.  Martin  Huemer 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Dr. med. univ. Martin HuemerMedizinische Klinik m.S. KardiologieCharité Campus Virchow Klinikum
    • Mr.  Dr. med. univ.  Martin  Huemer 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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