Control of bleeding in surgical procedures: critical appraisal of HEMOPATCH (Sealing Hemostat)

Figures & data

Figure 1 HEMOPATCH (Sealing Hemostat) is a next-generation hemostatic pad.

Notes: HEMOPATCH is composed of a bovine collagen backing and pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate (NHS-PEG) monomer that seals and induces hemostasis of bleeding tissue. The blue squares in the HEMOPATCH indicate the nonactive side and are spaced 1 cm apart.
Abbreviation: NHS-PEG, N-hydroxysuccinimide functionalized polyethylene glycol.

Figure 2 HEMOPATCH (Sealing Hemostat) binds to tissue through covalent amide bonds between PEG and tissue proteins and collagen.

Abbreviations: Lys, lysine; N-t, N-terminus; NHS-PEG, N-hydroxylsuccinimide functionalized polyethylene glycol.

Figure 3 HEMOPATCH (Sealing Hemostat) collagen has an open pore structure that absorbs excess tissue fluid and delivers NHS-PEG to the tissue surface.

Notes: The active surface is positioned upward and the open pore structure is seen throughout the collagen cross section using (A) stereoscopy imaging and (B) SEM imaging. Pockets of NHS-PEG powder are seen on the active surface in the SEM image (arrows).
Abbreviations: NHS-PEG, N-hydroxylsuccinimide functionalized polyethylene glycol; SEM, scanning electron microscope.

Figure 4 HEMOPATCH (Sealing Hemostat) is applied to a partial nephrectomy in a swine.

Notes: The partial nephrectomy is ~1 cm deep. The bleeding tissue is identified (A), orientation of HEMOPATCH is confirmed (B), and complete hemostasis is achieved following application (C).

Figure 5 HEMOPATCH provided 100% hemostasis immediately after application, while TACHOSIL provided 80% hemostasis.

Notes: Kaplan–Meier plot for interval censored time of hemostasis, where the time interval during which hemostasis occurred is shaded. Adapted from Lewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014;2014:930803.⁴

Figure 6 HEMOPATCH provides superior hemostatic performance and significantly less blood loss than TACHOSIL.

Notes: Odds ratio of hemostatic success and 95% CI, where the odds ratio of hemostatic success of HEMOPATCH is divided by that of TACHOSIL (A). HEMOPATCH had a statistically significant, at the 5% level, superior hemostatic success over time as the lower 95% CI is >1. Difference in rate of blood loss from lesions treated with HEMOPATCH and those treated with TACHOSIL, where the bleeding rate of TACHOSIL is subtracted from that of HEMOPATCH (B). HEMOPATCH had a statistically significant, at the 5% level, less bleeding rate over time as the upper 95% CI is <0. Adapted from Lewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014;2014:930803.⁴
Abbreviation: CI, confidence interval.

Table 1 HEMOPATCH (Sealing Hemostat) can withstand normal pressures of fluid-filled cavities when applied in the presence and absence of blood on a tissue substrate

Fluid-filled cavity	Normal pressure of cavity (mmHg)	Burst pressure of HEMOPATCH (mmHg)
Subarachnoid space	7–15	19.8–38.2
Gallbladder	2.1–12.2	19.0–23.6
Lymphatic system	–a	29.9–32.8
Urinary bladders	5–25	19.0–36.5

Notes:

a Data not available. Data from Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: a polyethylene glycol-coated collagen pad. J Biomater Appl. 2014;29(5):780–788.¹⁵

LewisKMMcKeeJSchivizABauerAWolfseggerMGoppeltARandomized, controlled comparison of advanced hemostatic pads in hepatic surgical modelsISRN Surg2014201493080324729905

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LewisKMSpaziererDSlezakPBaumgartnerBRegenbogenJGulleHSwelling, sealing, and hemostatic ability of a novel biomaterial: a polyethylene glycol-coated collagen padJ Biomater Appl201429578078825085811

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