Intra-operative Use of Hemopatch®: Interim Results of a Nationwide European Survey of Surgeons

Abstract:

Introduction: Haemostasis is a critical part of surgery. Haemostatic agent selection is based upon a number of factors including surgeon’s experience and choice. This post-marketing survey determined surgeons’ intraoperative use and perception of Hemopatch® (Baxter Healthcare Corporation, Deerfield, IL), a resorbable collagen-based sealing haemostat.
Methods and Participants: A one-arm questionnaire was distributed to European general, cardiac, pulmonary, and urologic surgeons who used Hemopatch® to achieve haemostasis in situations where bleeding control by pressure, ligature, or conventional procedures had been ineffective or was impractical. Responses were summarized for patient characteristics, surgical procedures/techniques, and surgeons’ assessment of Hemopatch® regarding their overall satisfaction and utilization characteristics of Hemopatch®.
Results: Of 1028 responses received from seven European countries, the majority were from Germany (47.3%) or Italy (36%). Most cases were in males (60.7%), 50–75 years of age (61.8%), performed by an open approach (82.5%), with 52.7% general-, 16.2% cardiac-, 7.5% lung, 19.5% urologic-type procedures and 3.7% other/unknown. Successful haemostasis after two minutes of approximation occurred in 93.3% of patients (86.8%-96.9% across surgical subtypes), with similar rates by approach (93.1% open; 94.1% minimally-invasive), and patient’s use of anticoagulant and/or antiplatelet agents (87.9% - 93.1%). Over 92% of surgeon’s rated Hemopatch® as “excellent” or “good” in assessments of overall satisfaction, haemostasis efficacy, ease of preparation, ease of handling, flexibility/pliability, and tissue adherence. These characteristics were rated as excellent or good by 81% or more of surgeons in analyses by surgical subspecialty and surgical approach of open or minimally invasive.
Conclusions: Hemopatch® provides effective haemostasis across a variety of surgical procedures, both in open- and minimally-invasive, as well as in patients receiving anticoagulant and/or antiplatelet agents. Surgeon’s generally rated their overall satisfaction with Hemopatch®, its haemostatic efficacy, and other characteristics as “much better” or “better” than their previously used haemostat.

Authors:

Frank Ulrich, MD, PhD, Head of Department, Dept. of General, Visceral, and Oncological Surgery, Wetzlar Hospital and Clinics, Wetzlar, Germany, Giuseppe Maria Ettorre, MD, Multiorgan Transplantation Program, General Surgery and Transplantation Unit, San Camillo Hospital, Rome, Italy, Luca Weltert, MD, European Hospital, Division of Cardiac Surgery, Rome, Italy, Martin Oberhoffer, MD, Cardiac Surgeon, Department of Cardiac Surgery, Asklepios Clinic St. Georg, Hamburg, Germany, Huub Kreuwel, PhD, Director, Global Medical Affairs, BioSurgery, Baxter Healthcare Corporation, Westlake Village, California, Rafaella De Santis, BS, Medical Scientific Liaison, Medical Affairs Department, BioSurgery, Baxter SpA, Rome, Italy, Erik Kuntze, MD, Medical Director, BioSurgery EMEA, Baxter Healthcare SA, Thurgauerstrasse, Zurich

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Histological Benefits of Sealants in Tracheal Lesions in Wistar Rats

Abstract:

Introduction: The purpose of our study was to compare the effect, on the inflammatory response and fibrosis formation, of four commercially available sealant products applied on an injured trachea in a Wistar rat population.
Materials and Methods: We compared four different sealants: cyanoacrylate, fibrin/thrombin, albumin/glutaraldehyde, and polyethylene glycol-based hydrogel (PEG). Rats were organized into six groups of similar size. Four of them were experimental, one was a baseline control group (BCG), and the sixth one was a reference control group (RCG). The RCG and experimental groups underwent the same surgical intervention with tracheal puncture, but no sealant was applied in the RCG. The BCG underwent the same cervical and peritracheal dissection without tracheal puncture. Rats were euthanized after eight weeks.
Results: The operation was performed on 54 rats, of which 12 died, leaving a final sample of 42 rats. Macroscopic analysis revealed no superficial tracheal or vascular fistulas, nor signs of local abscess. Although the groups treated with cyanoacrylate, fibrin/thrombin, and albumin/glutaraldehyde showed some degree of fibrosis, the treated area of the PEG group showed neither inflammatory nor scar signs. Microscopic assessment of the BCG and RCG showed no remarkable findings. With the exception of the PEG group, which had a light fibrosis and poor inflammatory response as did the BCG and RCG groups, the other groups showed varying degrees of fibrosis and cicatrization.
Conclusion: Our study showed that the group treated with PEG had a mild inflammatory and fibrotic response, which is useful in tracheal or tracheobronchial surgical procedures. However, groups treated with cyanoacrylate, fibrin/thrombin, and albumin/glutaraldehyde showed fibrosis and cicatrization.

Authors:

Luis Jorge Cerezal-Garrido, MD, PhD, Head, Thoracic Surgery Department, Hospital General Universitario de Alicante, Alicante, Spain, Associate Professor , Faculty of Medicine , Universidad Miguel Hernández, Elche (Alicante), Spain, Javier Agudo-Bernal, MD, PhD, Professor of Histology, Universidad de Valladolid, Valladolid, Spain, Carlos Vaquero-Puerta, MD, PhD, Director of Laboratory of Surgical Research and Experimental Techniques, Universidad de Valladolid, Valladolid, Spain

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A Modified Fisherman’s Knotfor Laparoscopic Suturing

Abstract:

Suturing is an essential surgical technique, because there is no resection without the need for reconstruction. Therefore, every surgeon should master a set of suturing techniques so he can adapt his approach to the specificity of the situation. The development of laparoscopic surgery poses a new challenge as not all open techniques are amendable for laparoscopic use. We would like to propose a modified fisherman’s knot, which has been optimised in our center for laparoscopic use. The technique can be used with every monofilament non-braided wire. The needle is placed through the tissue to be sutured and both wires are externalised through the trocar. First, a simple knot is placed by crossing the left over the right wire. Next, the left is turned around the right wire four times proximal to the starting knot and crossed to the left wire where an additional two turns are made moving away from the trocar. The knot is closed gently, making sure not to lock the knot. Then the instrument of Drouard is used to gently glide the knot over the right wire back through the trocar into the abdomen. After making sure that adequate pressure has been delivered to the knot, to firmly close the tissue, the wire must be cut at a length of at least 3 mm. A new wire should be used for every knot and in this manner several knots can be delivered to make sure the tissue is adequately closed. In our center, no known complications due to loosening or failure of these knots have occurred since we incorporated this knotting technique into our daily practice more than 20 years ago.

Authors:

Diederik Meylemans, MD , Fellow, Karen Handojo, MD , Resident, Kurt Devroe, MD, Consultant, Chris Aelvoet, MD , Consultant, Koen Vermeiren, MD , Consultant, Tim Tollens, MD, Consultant, Head of Department, Department of Abdominal Surgery, Imelda Hospital, Bonheiden, Belgium

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