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.
