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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05164809
Other study ID # 202101
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date February 2022

Study information

Verified date January 2022
Source University Hospital Muenster
Contact Jan Puetzler, Medical doctor
Phone 00492518359232
Email jan.puetzler@ukmuenster.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Resection of malign musculoskeletal tumors and reconstruction with large tumor prostheses often results in relevant blood loss requiring hemodynamic stabilization and transfusion. The use of novel electrosurgical electrodes is assessed retrospectively regarding the potential to reduce blood loss and the need for transfusions.


Description:

Background Resection of malign musculoskeletal tumors and reconstruction with large tumor prostheses often result in relevant blood loss requiring hemodynamic stabilization and transfusion. Since machine autotransfusion is contraindicated in tumor surgery, other measures are necessary to reduce intraoperative blood loss. Objectives Tungsten needle electrodes can be used to simultaneously cut skin and seal bleeding vessels for superficial dissection. Spatula electrodes coated with Teflon (polytetrafluoroethylene PTFE) are used for coagulation and dissection of deeper tissues. The coating reduces eschar build-up and thus smoke creation compared to conventional stainless-steel electrodes. This study assesses the effect of these novel electrodes on blood loss and transfusion rates. Methods: The investigators retrospectively investigate all cases of tumor resection and reconstruction with tumor prostheses that were operated five years before the introduction of the new electrodes (2012-2016) and five years after (2018-2021) by one single surgeon with over 25 years of experience. Data are extracted from digital patient records and analyzed by descriptive statistics and t-test for normally distributed data or Mann-Whitney test in case of non-normal distribution.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date February 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who received hemipelvectomy, hip disarticulation, or major tumor prosthesis implantation at our hospital between 2010 and 2021 - Operated by one single surgeon Exclusion Criteria: - Implantation of a Megaprosthesis without history of tumor

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Application of novel electrodes
Application of novel electrodes since 2017 for the dissection of extremity tumors in tumororthopedics

Locations

Country Name City State
Germany University Hospital Muenster Münster NRW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood loss monitored during surgery in the anaesthesiology protocol during surgery
Primary Transfusion of red packed blood cells number of intraoperative units of packed red blood cells during surgery
Primary Transfusion of red packed blood cells number of intraoperative units of packed red blood cells 14 days post surgery
Secondary post surgical wound drainage assessed via recorded volume 5 days post surgey
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