Table 1.
Inflammation pattern A: granulomatous with eosinophil-like cell infiltration; pattern B: granulomatous with few/no eosinophil-like cells.
| Inflammation pattern |
Eosinophils |
Epithelioid/giant cells | Lymphocytes | Plasma cells | B cells | Residual sealant | ||
|---|---|---|---|---|---|---|---|---|
| Test item | HE | HE | Lunaa | HE | HE | HE | Anti-CD79ab | HEc |
| BioGlue | A | 2 | 2 | 1 | 2 | 2 | 1 | 3 |
| BioGlue | A | 3 | 2 | 1 | 2 | 2 | 1 | 3 |
| BioGlue | A | 2 | 2 | 1 | 2 | 1 | 3 | 2 |
| BioGlue | A | 3 | 3 | 1 | 2 | 2 | 3 | 2 |
| BioGlue | A | 2 | 2 | 1 | 2 | 1 | 2 | 3 |
| BioGlue | A | 2 | 2 | 2 | 2 | 3 | 3 | 2 |
| BioGlue | A | 2 | 3 | 1 | 2 | 1 | 3 | 2 |
| BioGlue | A | 3 | 3 | 2 | 3 | 2 | 3 | 3 |
| BioGlue | A | 2 | 2 | 2 | 3 | 2 | 3 | 3 |
| Median | – | 2 | 2 | 1 | 2 | 2 | 3 | 3 |
| Mean | 2.33 | 2.33 | 1.33 | 2.22 | 1.77 | 2.44 | 2.56 | |
| SD | 0.5 | 0.5 | 0.5 | 0.44 | 0.67 | 0.88 | 0.53 | |
| Coseal | B | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Coseal | B | 0 | 0 | 2 | 1 | 0 | 1 | 1 |
| Coseal | B | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Coseal | B | 0 | 0 | 1 | 1 | 1 | 0 | 1 |
| Coseal | A | 2 | 1 | 2 | 2 | 0 | 2 | 1 |
| Coseal | B | 0 | 0 | 1 | 1 | 0 | 0 | 2 |
| Coseal | B | 1 | 1 | 2 | 1 | 1 | 2 | 2 |
| Coseal | – | 1 | 0 | 0 | 1 | 0 | 2 | 0 |
| Coseal | B | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
| Median | – | 0 | 0 | 1 | 1 | 0 | 1 | 1 |
| Mean | – | 0.44 | 0.22 | 1 | 1.11 | 0.22 | 0.89 | 0.89 |
| SD | 0.73 | 0.44 | 0.87 | 0.33 | 0.44 | 0.93 | 0.78 | |
| p-value | – | 0.0003 | <0.0001 | 0.5 | 0.0003 | 0.0004 | 0.003 | 0.0006 |
Grading defined qualitatively on a scale of 0 (no cells) to 3 (high infiltration of cells).
aGrading defined as cells per high-power field as follows: grade 0, 5 cells; grade 1, 5–<100 cells; grade 2, 100–500 cells; grade 3, >500 cells.
bGrading defined as follows: grade 0, no positive cells in any area; grade 1, <10 positive cells in each area; grade 2, 10–150 positive cells in areas of most intense infiltration; grade 3, >150 positive cells within a set area.
cGrading defined qualitatively as extent of residual sealant as follows: grade 0, no residual sealant; grade 1, minimal residual sealant; grade 2, moderate quantity of residual sealant; grade 3, large quantity of residual sealant. p-Values calculated using a Mann–Whitney U test.