Abstract PO5-19-09: Trial in progress: A prospective randomized, controlled study to evaluate device efficacy for cutting and/or coagulation of tissue during mastectomy procedures

Abstract

Abstract Background/Purpose: The ConMed HelixAR Electrosurgical Generator with Argon Beam Coagulation Technology (CHEST) trial aims to focus on patients undergoing mastectomy, either unilateral or bilateral, with immediate breast reconstruction including breast implants, tissue expander placement, or autologous flap. The study design follows the standard of care procedure with device efficacy being measured between two devices regularly used in the operative setting: the HelixAR Electrosurgical Generator (HEG) and the Conventional Electrosurgical Coagulation (CEC) systems. The need for safe alternative surgical tools is increasing as the number of women needing surgical treatment increases. Allowing for the test and comparison of these standardized devices gives an extent to the advantages of using one over the other. To evaluate the device effectiveness between the HelixAR Electrosurgical Generator and Conventional Electrosurgical Coagulation systems for cutting and/or coagulation of tissue during mastectomy and reconstruction surgery, we report the implementation in a randomized clinical trial. The study is powered to show superiority of the HEG to the CEC as it relates to the primary objective of time from post-mastectomy to hemostasis. The HEG is designed to deliver argon gas and high frequency electrical current compared to the CEC delivering high frequency electrical current only. The primary efficacy measure is the time it takes from post-mastectomy to hemostasis with the secondary effectiveness endpoints being infection, drain duration, total drain output, blood loss and device related adverse events. The study hypothesizes that the time for post-mastectomy hemostasis is significantly less for the HEG than the CEC. Additional hypotheses include overall less device related adverse events, lower blood loss, and reduced operative time in favor of the HEG. Methods: This is a prospective 1:1 randomized controlled study of the HEG versus the CEC for patients undergoing a mastectomy with reconstruction procedure. 82 patients will be enrolled and distributed in two arms of 41 patients with a primary objective to assess the device efficacy for cutting and coagulation. The subject population includes patients with breast cancer or high risk from genetic mutations and/or family history. Exclusion factors include known history of bleeding diathesis or coagulopathy, advanced refusal of blood transfusion, active systemic or cutaneous infection or inflammation. The enrolled patients will be followed for 2 months post-operatively. Results: The study is open with 53/82 (65%) patients enrolled at the time of the abstract submission. Of those, 26 subjects were randomized to the CEC and 27 to the HEG. 27 subjects have experienced an adverse or serious adverse event including bruising, infections, and wound dehiscence, none determined to be related to the device use. For the study, analysis will focus on the primary endpoint comparing post–mastectomy procedure time to hemostasis between the two devices. Conclusion: The CHEST trial demonstrates the feasibility of conducting a randomized controlled trial at a single center in a complex operative setting comparing two surgical modalities. The testing of these surgical devices provides rationale for the implementation of safe and regulated clinical trials. While both devices are FDA approved and regularly used, the standardization of device efficacy is becoming more prevalent as new innovations get introduced into the surgical setting. Citation Format: Jessica Montalvan, Ivan Marin, Logan Healy, Margarita Riojas-Barrett, Mary Bajomo, Elizabeth Bonefas, Alastair Thompson, Marco Maricevich, Sebastian Winocour, Stacey Carter. Trial in progress: A prospective randomized, controlled study to evaluate device efficacy for cutting and/or coagulation of tissue during mastectomy procedures [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-19-09.