Clinical Trials Directory

Trials / Unknown

UnknownNCT05164809

Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery

Effect of Monopolar Tungsten Needle Electrodes and Teflon Coated Spatula Electrodes on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery Compared to Conventional Surgical Knives and Stainless-Steel Electrodes

Status
Unknown
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
University Hospital Muenster · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICEApplication of novel electrodesApplication of novel electrodes since 2017 for the dissection of extremity tumors in tumororthopedics

Timeline

Start date
2021-10-01
Primary completion
2022-01-01
Completion
2022-02-01
First posted
2021-12-21
Last updated
2022-01-18

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT05164809. Inclusion in this directory is not an endorsement.