Surgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch® is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch® for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had received Hemopatch® during an open or minimally invasive procedure in one of these specialties: hepatobiliary, cardiovascular, urological, neurological/spinal, general, or lung surgery. Patients were excluded if they had a known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile or severe bleeding and/or infection at the target application site (TAS). The primary endpoint for intraoperative effectiveness was hemostasis assessed as the percentage of patients achieving hemostasis within 2 min and the percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure. The registry enrolled 621 patients at 23 study sites in six European countries. Six hundred twenty patients had completed follow-up information. Hemostasis within 2 min was achieved at 463 (74.5%) of all 621 TASs. Hemostasis without re-bleeding was observed at 620 (99.8%) TASs. Adverse events were reported in 64 patients (10.3%). This Hemopatch® registry shows that Hemopatch® efficiently establishes hemostasis and sealing in a variety of surgical specialties, including minimally invasive procedures. Furthermore, we provide evidence for the safety of Hemopatch® across all the specialties included in the registry. This study is registered at clinicaltrials.gov: NCT03392662.

Clinic for Urology Vivantes Auguste Viktoria Klinikum Berlin Germany

Clinic for Vascular Surgery Samodzielny Public Hospital Szczecin Poland

Department of Pediatric Surgery Hospital Universitario Virgen del Rocio Seville Spain

Department of Surgery Hospital La Paz Madrid Spain

Division of General and Transplant Surgery University of Pisa Pisa Italy

General Surgery Unit Azienda Ospedaliera per l'Emergenza Cannizzaro Catania Italy

Hepatobiliary and Pancreatic Surgery Unit Hospital Universitari de Girona Doctor Josep Trueta Girona Spain

Neurosurgical Clinic University Hospital Ostrava Poruba Czech Republic

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Zegers M, de Bruijne MC, de Keizer B, Merten H, Groenewegen PP, van der Wal G, Wagner C. The incidence, root-causes, and outcomes of adverse events in surgical units: implication for potential prevention strategies. Patient Saf Surg. 2011;5:13. doi: 10.1186/1754-9493-5-13. PubMed DOI PMC

Bracey A, Shander A, Aronson S, Boucher BA, Calcaterra D, Chu MWA, Culbertson R, Jabr K, Kehlet H, Lattouf O, Malaisrie SC, Mazer CD, Oberhoffer MM, Ozawa S, Price T, Rosengart T, Spiess BD, Turchetti G. The use of topical hemostatic agents in cardiothoracic surgery. Ann Thorac Surg. 2017;104(1):353–360. doi: 10.1016/j.athoracsur.2017.01.096. PubMed DOI

Lewis KM, Ikeme S, Olubunmi T, Kuntze CE. Clinical effectiveness and versatility of a sealing hemostatic patch (HEMOPATCH) in multiple surgical specialties. Expert Rev Med Dev. 2018;15(5):367–376. doi: 10.1080/17434440.2018.1464909. PubMed DOI

Light RU, Prentice HR. Surgical investigation of a new absorbable sponge derived from gelatin for use in hemostasis. J Neurosurg. 1945;2(5):435–455. doi: 10.3171/jns.1945.2.5.0435. DOI

Lewis KM, Kuntze CE, Gulle H. Control of bleeding in surgical procedures: critical appraisal of HEMOPATCH (Sealing Hemostat) Med Devices (Auckl) 2015;22(9):1–10. doi: 10.2147/MDER.S90591. PubMed DOI PMC

Fingerhut A, Uranues S, Ettorre GM, Felli E, Colasanti M, Scerrino G, Melfa GI, Raspanti C, Gulotta G, Meyer A, Oberhoffer M, Schmoeckel M, Weltert LP, Vignolini G, Salvi M, Masieri L, Vittori G, Siena G, Minervini A, Serni S, Carini M. European initial hands-on experience with HEMOPATCH, a novel sealing hemostatic patch: application in general, gastrointestinal, biliopancreatic, cardiac, and urologic surgery. Surg Technol Int. 2014;25:29–35. PubMed

Imkamp F, Tolkach Y, Wolters M, Jutzi S, Kramer M, Herrmann T. Initial experiences with the Hemopatch(R) as a hemostatic agent in zero-ischemia partial nephrectomy. World J Urol. 2015;33(10):1527–1534. doi: 10.1007/s00345-014-1404-4. PubMed DOI

Ruggiero R, Docimo L, Tolone S, De Palma M, Musella M, Pezzolla A, Gubitosi A, Parmeggiani D, Pirozzi R, Gili S, Parisi S, D'Alessandro A, Docimo G. Effectiveness of an advanced hemostatic pad combined with harmonic scalpel in thyroid surgery. A prospective study. Int J Surg (Lond, Engl) 2016;28(Suppl 1):S17–21. doi: 10.1016/j.ijsu.2015.12.044. PubMed DOI

Prasad M, Mukerji N. Case report of a novel technique for repair of the vertebral artery during cranial surgery. Neurol Therapy. 2019;8(2):505–509. doi: 10.1007/s40120-019-0142-3. PubMed DOI PMC

Schebesch KM, Brawanski A. Clinical experience with Hemopatch(R) as a dural sealant in cranial neurosurgery. Cureus. 2019;11(2):e4013. doi: 10.7759/cureus.4013. PubMed DOI PMC

Hupe MC, Büttner M, Tabrizi PF, Merseburger AS, Kuczyk MA, Imkamp F. Hemopatch(®) as a hemostatic agent is safe in partial nephrectomy: a large, single-surgeon retrospective evaluation. Adv Ther. 2020 doi: 10.1007/s12325-020-01584-8. PubMed DOI PMC

Weltert L, D'Aleo S, Chirichilli I, Falco M, Turani F, Bellisario A, De Paulis R. Prospective Randomized Clinical Trial of HEMOPATCH Topical Sealant in Cardiac Surgery. Surg Technol Int. 2016 Oct;XXIX:sti29:756. PubMed

Di Cesare T, Scarinci A, Cavaniglia D, Brun S, Cilurso F, Cosenza G, Grillo M, Costigliola L, Di Gioia G, Perfetto D, Buonanno GM, Travaglino A, Liverani A. Efficacy of Hemopatch® in reducing postoperative bleeding after laparoscopic cholecystectomy: Prospective and multicenter study. Integr Clin Med. 2018;2(4):1–3. doi: 10.15761/ICM.1000133. DOI

Nowak S, Schroeder HWS, Fleck S. Hemopatch((R)) as a new dural sealant: a clinical observation. Clin Neurol Neurosurg. 2019;176:133–137. doi: 10.1016/j.clineuro.2018.12.009. PubMed DOI

Pisapia A, Crolla E, Saracco M, Saglioccolo A, Dolce P, Molino C. The effectiveness of Hemopatch™ in preventing postoperative distal pancreatectomy fistulas. Expert Rev Med Dev. 2019;16(3):253–256. doi: 10.1080/17434440.2019.1582328. PubMed DOI

Ulrich F, Ettorre GM, Weltert L, Oberhoffer M, Kreuwel H, De Santis R, Kuntze E. Intra-operative use of Hemopatch(R): interim results of a nationwide European survey of surgeons. Surg Technol Int. 2016;28:19–28. PubMed

Olthof PB, Rassam F, van Gulik TM. The use of a NHS-PEG coated, collagen-based sealant in a patient undergoing Associating Liver Partition and Portal vein Ligation for Staged hepatectomy (ALPPS) Int J Surg Case Rep. 2018;47:7–10. doi: 10.1016/j.ijscr.2018.03.038. PubMed DOI PMC

Uranues S, Fingerhut A, Belyaev O, Zerbi A, Boggi U, Hoffmann MW, Reim D, Esposito A, Primavesi F, Kornprat P, Coppola R, Fragulidis GP, Serradilla-Martin M, Alimoglu O, Peri A, Diaconescu B. Clinical impact of stump closure reinforced with hemopatch on the prevention of clinically relevant pancreatic fistula after distal pancreatectomy: a multicenter randomized trial. Ann Surg Open. 2021;2(1):e033. doi: 10.1097/as9.0000000000000033. PubMed DOI PMC

Ho Y-F, Hu F-C, Lee P-I. The advantages and challenges of using real-world data for patient care. Clin Transl Sci. 2020;13(1):4–7. doi: 10.1111/cts.12683. PubMed DOI PMC

Lewis KM, Li Q, Jones DS, Corrales JD, Du H, Spiess PE, Lo Menzo E, DeAnda A., Jr Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents. Surgery. 2017;161(3):771–781. doi: 10.1016/j.surg.2016.09.022. PubMed DOI

HEMOPATCH® . Sealing Hemostat-instructions for use BE-30–03–130. Zurich: Baxter Healthcare SA; 2018.

Genyk Y, Kato T, Pomposelli JJ, Wright JK, Jr, Sher LS, Tetens V, Chapman WC. Fibrin sealant patch (TachoSil) vs oxidized regenerated cellulose patch (Surgicel Original) for the secondary treatment of local bleeding in patients undergoing hepatic resection: a randomized controlled trial. J Am Coll Surg. 2016;222(3):261–268. doi: 10.1016/j.jamcollsurg.2015.12.007. PubMed DOI

Maisano F, Kjaergård HK, Bauernschmitt R, Pavie A, Rábago G, Laskar M, Marstein JP, Falk V. TachoSil surgical patch versus conventional haemostatic fleece material for control of bleeding in cardiovascular surgery: a randomised controlled trial. Eur J Cardiothorac Surg. 2009;36(4):708–714. doi: 10.1016/j.ejcts.2009.04.057. PubMed DOI

Siemer S, Lahme S, Altziebler S, Machtens S, Strohmaier W, Wechsel HW, Goebell P, Schmeller N, Oberneder R, Stolzenburg JU, Becker H, Lüftenegger W, Tetens V, Van Poppel H. Efficacy and safety of TachoSil as haemostatic treatment versus standard suturing in kidney tumour resection: a randomised prospective study. Eur Urol. 2007;52(4):1156–1163. doi: 10.1016/j.eururo.2007.04.027. PubMed DOI

Ramirez MG, Serradilla M, Ramirez MA. Cost-benefit analysis: hemopatch® vs standard of care in the incidence of postoperative pancreatic fistula in a observational study. Am J Biomed Sci Res. 2019;1(1):11–19. doi: 10.34297/AJBSR.2019.01.000504. DOI

Anderson PA, Savage JW, Vaccaro AR, Radcliff K, Arnold PM, Lawrence BD, Shamji MF. Prevention of surgical site infection in spine surgery. Neurosurgery. 2017;80(3s):S114–S123. doi: 10.1093/neuros/nyw066. PubMed DOI

Real-World Data on the Usage of Hemopatch® as a Hemostat and Dural Sealant in Cranial and Spinal Neurosurgery

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ClinicalTrials.gov
NCT03392662