Abstract P2-12-28: A prospective randomized, controlled study to evaluate device efficacy for cutting and/or coagulation of tissue during mastectomy procedures

Abstract Background/Purpose: The ConMed HelixAR Electrosurgical Generator with Argon Beam Coagulation Technology (CHEST) trial focuses on patients undergoing unilateral or bilateral mastectomy with immediate breast reconstruction including breast implants, tissue expander placement, or autologous flap. The study design compares time to hemostasis between two devices: the HelixAR Electrosurgical Generator (HEG) and the Conventional Electrosurgical Coagulation (CEC) system. 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 their 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 key efficacy measure is post-mastectomy time to hemostasis with the secondary endpoints of wound 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 fewer device related adverse events, lower blood loss, and reduced operative time. Methods: This ongoing 1:1 randomized controlled trial plans to enroll 82 patients undergoing mastectomy with reconstruction. The population includes women with breast cancer and/or high risk of developing breast cancer from genetic mutations and family history. Exclusion factors include known history of bleeding diathesis or coagulopathy, advanced refusal of blood transfusion, active systemic or cutaneous infection or inflammation. Participants are randomly allocated to either the HEG or the CEC at the time of surgery. The surgeons are instructed to use the randomized device throughout the procedure with primary endpoints focused on evaluating device efficacy for cutting and coagulation. Subjects are monitored for 2 months post-operatively to assess perioperative outcomes. Results: At the time of abstract submission, 80 patients were enrolled, with 39 allocated to HEG and 40 to the CEC (1 pending randomization). 48 subjects experienced an adverse or serious adverse event including bruising, infections, and wound dehiscence. It has been determined that none of these reported events are related to device use. Preliminary findings indicate a marked reduction in hemostasis time with the HEG compared to the CEC. Conclusion: The trial demonstrates the feasibility of conducting a randomized controlled trial at a single center in a complex operative setting comparing two FDA approved surgical devices. The final analysis will show whether the HEG improves hemostasis in women undergoing mastectomy with reconstruction. Citation Format: Jessica Montalvan, Margarita Riojas-Barrett, Bernardo Martinez Leal, Nelly A. Hernandez, Ivan Marin, Logan Healy, Elizabeth Bonefas, Alastair M. Thompson, Marco Maricevich, Sebastian Winocour, Stacey A. Carter. A prospective randomized, controlled study to evaluate device efficacy for cutting and/or coagulation of tissue during mastectomy procedures [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P2-12-28.