Sealing effectiveness of a novel NHS-POx based patch: experiments in a dynamic ex vivo porcine lung

Abstract

Background Sealants are used to prevent prolonged pulmonary air leakage (PAL) after lung resections (incidence 5.6–30%). However, clinical evidence to support sealant use is insufficient, with an unmet need for a more effective product. We compared a novel gelatin patch impregnated with functionalized polyoxazolines (NHS-POx) (GATT-Patch) to commercially available sealant products. Methods GATT-Patch Single/Double layers were compared to Progel ® , Coseal ® , Hemopatch ® and TachoSil ® in an ex vivo porcine lung model (first experiment). Based on these results, a second head-to-head comparison between GATT-Patch Single and Hemopatch ® was performed. Air leakage (AL) was assessed in three settings using increasing ventilatory pressures (max =70 cmH 2 O): (I) baseline, (II) with 25 mm × 25 mm superficial pleural defect, and (III) after sealant application. Lungs floating on saline (37 ℃) were video recorded for visual AL assessment. Pressure and tidal volumes were collected from the ventilator, and bursting pressure (BP), AL and AL-reduction were determined. Results Per sealant 10 measurements were performed (both experiments). In the first experiment, BP was superior for GATT-Patch Double (60±24 cmH 2 O) compared to TachoSil ® (30±11 cmH 2 O, P<0.001), Hemopatch ® (33±6 cmH 2 O, P=0.006), Coseal ® (25±13 cmH 2 O, P=0.001) and Progel ® (33±11 cmH 2 O, P=0.005). AL-reduction was superior for GATT-Patch Double (100%±1%) compared to Hemopatch ® (46%±50%, P=0.010) and TachoSil ® (31%±29%, P<0.001), and also for GATT-Patch Single (100%±14%, P=0.004) and Progel (89%±40%, P=0.027) compared to TachoSil ® . In the second experiment, GATT-Patch Single was superior regarding BP (45±10 vs. 40±6 cmH 2 O, P=0.043) and AL-reduction (100%±11% vs. 68%±40%, P=0.043) when compared to Hemopatch ® . Conclusions The novel NHS-POx patch shows promise as a lung sealant, demonstrating elevated BP, good adhesive strength and a superior AL-reduction.

Prolonged air leak after lung surgery—prevalent complication without a perfect solution

“…Given the different mechanical characteristics and modes of action of surgical sealants and the paucity of literature comparing between them, Hermans and colleagues in their article, “Sealing effectiveness of a novel NHS-POx based patch: experiments in a dynamic ex vivo porcine lung” compare a novel patch based on porcine derived gelatin impregnated with functionalized polyoxazolines (GATT patch, GATT Technologies BV, Nijmegen, The Netherlands) to commercial gels (Progel, C.R. Bard Inc., Murray Hill, NJ, USA; Coseal, Baxter International Inc., Deerfield, IL, USA) and patch sealants (Hemopatch, Baxter International Inc. and Tachosil, Takeda Pharmaceutical Company Limited, Tokyo, Japan) products ( 6 ). The investigation and comparison of the aerostatic properties of this novel product with commercial products mentioned above were conducted in an ex - vivo porcine lung model.…”