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Effect of multiple use and sterilization on sealing performance of bipolar vessel sealing devices.

ABSTRACT: BACKGROUND:Advanced bipolar vessel sealing devices are widely used in human and veterinary medicine to reduce the operation time and intraoperative blood loss. Because most devices are made for a single use, their application is cost intensive. The aim of this study was to investigate the influence of multiple uses and sterilization on the performance of bipolar vessel sealing devices. METHODS:The burst pressure of sealed porcine renal arteries was compared between the disposable devices "LigaSure"(Valleylab) and "Caiman"(Braun Vetcare) and the reuseable device "MarSeal"(KLS Martin). Additionally, the influence of the sterilization process was investigated, and the sealing time, number of cutting activations and tissue sticking were noted. RESULTS:The disposable devices showed reliable performances over multiple activations and sterilization cycles, except for one Caiman device. Seals created with all devices achieved supra-physiologic burst pressures, with the highest pressure measured in a cycle using a MarSeal device. DISCUSSION:During 25 activations with and without intermittent sterilization, no correlation was found between increasing seal numbers and decreasing burst pressure. However, the number of cycles in our study was limited to five. CONCLUSION:For limited numbers of cycles and sterilization procedures, seals created with the disposable vessel sealing devices LigaSure and Caiman achieved burst pressures comparaable to those produced with the reuseable MarSeal.

SUBMITTER: Gardeweg S

PROVIDER: S-EPMC6701801 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Effect of multiple use and sterilization on sealing performance of bipolar vessel sealing devices.

Gardeweg Silvia S Bockstahler Barbara B Duprè Gilles G

PloS one 20190820 8

<h4>Background</h4>Advanced bipolar vessel sealing devices are widely used in human and veterinary medicine to reduce the operation time and intraoperative blood loss. Because most devices are made for a single use, their application is cost intensive. The aim of this study was to investigate the influence of multiple uses and sterilization on the performance of bipolar vessel sealing devices.<h4>Methods</h4>The burst pressure of sealed porcine renal arteries was compared between the disposable ...[more]

PMID: 31430327

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Project description:BackgroundThe surgical technique used in liver transplantation has undergone constant evolution in an effort to develop a safe, highly standardized procedure. Despite this, the initial step of recipient hepatectomy has not been the focus of clinical research thus far. Due to advanced coagulopathy in liver transplant recipients, this part of the operation still carries the risk of severe hemorrhage. This trial is designed to compare an electrothermal bipolar vessel sealing device (LigaSure™) and an ultrasound dissector (HARMONIC ACE®+7) with standard surgical techniques during the recipients' hepatectomy in liver transplantation.Methods/designIn a single-center, prospective, randomized, controlled, parallel, three-armed, confirmatory, open trial, LigaSure™ and HARMONIC ACE®+7 will be compared with standard surgical techniques that use titanium clips and conventional knot-tying ligations during recipient hepatectomy in liver transplantation. Intraoperative total blood loss is the primary endpoint of the trial. Secondary endpoints include blood loss during hepatectomy, the duration of both the hepatectomy and the entire surgical procedure, and blood transfusion requirements of the procedure. To generate reliable data, intraoperative blood loss will be recorded with respect to all rinse fluids during surgery, ascites, and by weighing used swabs. At 80% power and an alpha of 0.025 for both of the experimental groups, 23 subjects will be analyzed per protocol in each study arm in order to detect clinically relevant reduction of intraoperative blood loss. The intention-to-treat analysis will include 69 patients. The follow-up period for each patient will be 90 days for safety reasons, whereas all clinical outcomes will be measured within the first 10 postoperative days.DiscussionTo our knowledge, this is the first prospective, randomized trial comparing two innovative technical methods of vessel sealing and dissection with standard techniques for recipient hepatectomy. This will be done to detect relevant reduction of intraoperative blood loss during liver transplant. The results of the trial are expected to improve patient outcome and safety after liver transplant and to increase the general safety of this procedure.Trial registrationClinicalTrials.gov, NCT 03323242 . Registered on October 26, 2017.

Project description:ObjectivesTo assess changes in quality of life after laparoscopic removal of Essure® sterilization devices (Bayer AG, Leverkusen, Germany).Study designIn this prospective observational study in an academic research hospital, 80 women with new or worsening symptoms since placement of Essure® sterilization devices undergoing subsequent surgical removal were included. Laparoscopic removal of Essure® devices and salpingectomy with or without cornual excision were performed. Concomitant uterine procedures could be associated where indicated for gynaecological complaints. Comparison using the T student test for coupled series was done in this before-and-after study.ResultsHealth related quality of life (HRQL) was the primary outcome measured by the Short Form 12 (SF-12) questionnaire and a global 10 cm visual analogue scale (VAS). Secondary outcomes included assessment of pain, using continuous (VAS) and ordinal scales (Modified McGill Pain Questionnaire), menstrual bleeding (pictorial blood loss assessment chart (PBAC) score) and surgical feasibility and safety. There was a significant improvement in quality of life in both mental and physical health aspects of the SF-12 (34.02 (+/-1.19) vs. 49.61 (+/-1.42, P < .0001) and 36.55 (+/-0.99) vs. 43.32 (+/-1.18, P < .0001 respectively) as well as global VAS assessment (+2.91 (SD +/-0.27)) at the end of the first post-operative month. These improvements were maintained at three and six months. Mean pain decreased at one month following surgery compared to baseline (VAS 3.6 (+/-0.36) to 1.4 (+/-0.25), P < .0001 and McGill pain score 18.70 (+/-1.88) to 4.73 (+/-0.90), P < .0001). Improvements of a similar magnitude were observed when analysis was restricted to the 47 women without concomitant uterine surgery. No significant changes in bleeding were seen following of Essure® device removal. Planned procedures were all successfully completed.ConclusionLaparoscopic removal of Essure® devices in symptomatic women is technically successful and associated with short and medium-term improvement in quality of life as well as reduction in pelvic pain.

Project description:BackgroundDifferent 3D-printed materials polyactic acid (PLA), polyamide (PA), polycarbonates (PC), acrylonitrile butadiene styrene (ABS) and GreenTEC Pro®I have been considered for surgical templates, but there is a sparity of data about how these materials are affected by steam sterilization. The aim of the current study was to test if and how these materials change morphologically when high temperature, pressure and humidity are applied during the steam sterilization process. The overall aim is to create patient-specific sawing templates for performing corrective osteotomies. After the designing process, test-specimens with five different materials: PLA, PC, ABS, PA and GreenTEC Pro® were 3D-printed in two filling grades (30 and 100%). The FDM method was used for printing. After 3D-printing, the test-specimens were steam sterilized with a standard program lasting 20 min, at a temperature of 121 °C and a pressure of 2-3 bar. In order to measure the deviation of the printed model, we measured the individual test-specimens before and after steam sterilization using a sliding gauge.ResultsPC, PA and ABS showed great morphological deviations from the template after 3D-printing and steam sterilization (> 1%) respectively. ABS proved unsuitable for steam sterilization. PLA and GreenTEC Pro® demonstrated fewer morphological deviations both before and after sterilization. Therefore, we decided to perform a second test just with PLA and Green-TEC Pro® to find out which material has the highest stability and is probably able to be used for clinical application. The smallest deviations were found with the GreenTEC Pro® solid body. After autoclaving, the specimens showed a deviation from the planned body and remained below the 1% limit.ConclusionSteam sterilization causes morphological deviations in 3D printed objects. GreenTEC Pro® seems to be a suitable material for clinical use, not only for intraoperative use, but also for precise modeling. Microbiological examination, as well as biomechanical tests, should be performed to further assess whether intraoperative use is possible.

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Effect of multiple use and sterilization on sealing performance of bipolar vessel sealing devices.

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Effect of multiple use and sterilization on sealing performance of bipolar vessel sealing devices.

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