The following is a summary of “Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5–7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial,” published in the July 2024 issue of Surgery by Wang et al.
The ultrasonic scalpel has become a fundamental tool in surgical procedures due to its efficacy and safety in managing various tissue types. It has been well-established that ultrasonic energy devices can reliably close pulmonary artery branch vessels up to 7 mm in diameter. However, the application of these devices for coagulating blood vessels in the range of 5–7 mm during thoracic surgery has not been thoroughly validated through multicenter randomized clinical trials. This study aims to fill this gap through a rigorous, prospective, multicenter, randomized, parallel-controlled, non-inferiority trial. The researchers will enroll 144 eligible patients scheduled to undergo lung or esophageal surgeries.
These patients will be randomly allocated to one of two groups: the experimental group, which will use the Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc., and the control group, which will use the Harmonic Ace+ 7, 5 mm Diameter Shears with Advanced Hemostasis. The trial’s primary objective is to assess the success rate of coagulating target blood vessels during surgery using these devices. To evaluate the comparative efficacy, the study group will measure secondary endpoints, including the incidence of postoperative rebleeding, intraoperative bleeding volume, total drainage volume, and the duration of the surgical procedures. Rigorous postoperative follow-up will be conducted to monitor patient outcomes before and after discharge. This study seeks to comprehensively evaluate the safety and effectiveness of the Disposable Ultrasonic Shears compared to the established Harmonic Ace+ 7 device.
By doing so, it aims to determine whether the investigational product meets or exceeds the performance of the control product in managing blood vessels in the specified size range, potentially leading to advancements in surgical practices and improved patient care in thoracic surgery. The results of this trial will be instrumental in guiding clinical decision-making, optimizing surgical techniques, and enhancing overall patient outcomes by providing robust evidence on the efficacy of ultrasonic shears for coagulation in a multicenter setting.
Source: bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02497-x