Clinical effectiveness and versatility of a sealing hemostatic patch (HEMOPATCH) in multiple surgical specialties

Figures & data

Figure 1. Flow diagram of literature search for clinical evidence of HEMOPATCH Sealing Hemostat in various surgical settings.

Table 1. Summary of clinical evidence by outcome and surgery setting for HEMOPATCH Sealing Hemostat.

Author	Weltert et al. [42]	Scheurer et al. [43]	Tardáguila et al. [49]^a	Ruggiero et al. [44]	Serradilla et al. [45]	Imkamp et al. [46]	González et al. [48]^a	Torres et al. [47]^a
Year	2016	2016	2017	2015	2017	2016	2017	2016
Publication type	Journal article	Abstract	Poster	Journal article	Poster	Abstract	Oral presentation	Poster
Country	Italy	Denmark	Spain	Italy	Spain	Germany	Spain	Spain
Level of evidence	I	I	II-3	II-3	II-3	II-3	II-3	III
Study type	RCT	RCT	Prospective observational	Prospective observational	Prospective observational	Prospective observational	Retrospective observational	Observational
Number of patients	170 (85 per group)	100 (50 per group)	136	60 (30 per group)	26 (13 per group)	19	200	12
Surgical setting	Cardiac	Hepatic	Neuro (dura)	Thyroid	Pancreatic	Renal	Neuro (dura)	Gastrointestinal
Interventions	HEMOPATCH v SOC	HEMOPATCH v TACHOSIL	HEMOPATCH	HEMOPATCH v SOC	HEMOPATCH v control^b	HEMOPATCH	HEMOPATCH	HEMOPATCH
Hemostasis efficacy, %	≤ = 3 minutes H: 97.6% SOC: 65.8% (p < 0.001)			Dry surgical field prior to drain placement H: 100% SOC: 85.6% (p < 0.001)
Transfusion requirements, %	H: 23.5% SOC: 34% (p = 0.24)
Drain output or blood loss, mL	Mean (SD), H v SOC 2 hr 110 (60) v 140 (50) (p = 0.01) 6 hr 380 (100) v 440 (110) (p = 0.02) 12 hr 550 (110) v 650 (120) (p = 0.05) 24 hr 730 (130) v 850 (140) (p = 0.08)			Mean (SD) 24 hr H: 50.1 (21.4) SOC: 90.3 (24.2) (p < 0.001)		Median (range) H: 325 (50–700)
Surgical revision due to bleeding, %	H: 4.7% SOC: 5.8% (p = 0.30)
Surgery time, minutes			No increase in surgical time with HEMOPATCH use	Mean (SD) H: 52.8 (16.2) SOC: 80.1 (21.2) (p < 0.001)		Median (range) H: 139 (103–194)
Length of stay, days				Mean (SD) H: 2.5 (0.56) SOC: 2.68 (0.58)	Mean H: 21.3 C: 26.1	Median (range) H: 6 (4–8)
Sealing efficacy, %		Success H: 70.1% T: 75.0% (p = 0.5 Fischer)						No patients with clinical and/or radiological leakage/dehiscence of the anastomosis
Complications, %			Craniotomy: 5 non-symptomatic postsurgical hematomas and 1 CSF fistula Endonasal: 2 CSF fistula	Surgical related H: 0% SOC: 10% Hypocalcemia H: 18.6% SOC: 21.7% (p = 0.37)	H v C PF 7.7% v 30.9% BF 7.7% v 15.4% DGE 7.7% v 7.7% Readmission 7.7% v 46% OC 61.6% v 46.2% Exitus 0% v 7.7%	Pneumonia in one patient	CSF fistula reduced 26% preoperative to 8%. No secondary complications at 2-years of follow-up

^aPoster or presentation translated from Spanish. ^bIn the Control group, pancreaticoduodenectomy was performed using the same technique and without HEMOPATCH.

BF: biliary fistula; C: control; CSF: cerebrospinal fluid; DGE: delayed gastric emptying; H: HEMOPATCH; hr: hours; OC: other complications; PF: pancreatic fistula; SOC: standard of care – dry/wet gauze compress, ligature, electrocauterization; T: TACHOSIL

Weltert L, D’Aleo S, Chirichilli I, et al. Prospective randomized clinical trial of HEMOPATCH topical sealant in cardiac surgery. Surg Technol Int. 2016; XXIX. pii: sti29/756. [Epub ahead of print].

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Scheurer S, Schultz N, Storkholm J, et al. Comparison of two hemostatic agents (Hemopatch™ vs. TachoSil™) in liver resection, A clinical randomised trial. Hpb. 2016;18:e268.

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Tardáguila Serrano M, Gonçalves Ramírez FJ, Rimbau Muñoz J, et al. Use of hemostatic patterns as dural seals. Poster presented at: XXI Congreso de la Sociedad Española de Neurocirugía; Barcelona, Spain 2017.

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Ruggiero R, Docimo L, Tolone S, et al. Effectiveness of an advanced hemostatic pad combined with harmonic scalpel in thyroid surgery, A prospective study. Int J Surg. 2016;28:S17–S21.

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Serradilla M, Palomares A, Paterna S, et al. Sealing with NHS-PEG patch to prevent postoperative pancreatic fistula after pancreatojejunostomy. Poster presented at: 12th Biennial Congress of the European–African Hepato-Pancreato-Biliary Association; Mainz, Germany 2017.

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Imkamp F, Von Klot C, Wolters M, et al. The role of Hemopatch® in zero ischemia laparoscopic partial nephrectomy. Eur Urol Supplements. 2016;15:e858.

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González Pombo M, Rivero Garvia M, Rocha Romero S, et al. Dural reconstruction with heterologous plastia of collagen coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetrasuccinimidyl glutarate). Lessons learned and experience in 200 cases. Oral presented at: XXI Congreso de la Sociedad Española de Neurocirugía; Barcelona, Spain 2017.

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Torres Melero J, Vargas Fernández M, Lorenzo L, et al. Use of the hemopatch resorbable collagen-based sealing hemostat to reinforce bowel anastomoses made in patients with peritoneal carcinomatosis treated with curative intent by complete cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy (CRS + HIPEC). Poster presented at: XXXI Congreso Nacional de Cirugia Asociación Española de Cirgujanos; Madrid, Spain 2016.

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