Table 2

Study outcomes at week 10 for ChitoCare and placebo arms

ChitoCare armPlacebo armP value
Complete wound closure: patients with event/all (%)3/18 (16.7)1/24 (4.2)0.297*
75% wound closure: patients with event/all (%)8/18 (44.4)3/24 (12.5)0.033*
50% wound closure: patients with event/all (%)11/18 (61.1)7/24 (29.2)0.060*
Relative reduction in wound surface area, n total12180.008†
Median (Q1; Q3), %92.0 (61.6; 98.7)37.0 (−22.9; 68.4)‡
Mean (SD), %76.1 (31.9)20.5 (68.2)
Bates-Jensen Wound Assessment, n total1017
Relative change from baseline score: median (Q1; Q3), %−29.8 (−59.1; −15.8)−3.6 (−15.4; 3.7)0.010†
Relative change from baseline score: mean (SD), %−34.0 (22.6)−10.3 (25.5)
Score§ at week 10: median (Q1; Q3)20 (10; 22)24 (21; 28)0.018†
Adverse events; no. of patients with (%)6 (33.3)4 (16.7)0.281*
Infection of primary wound, n (%)2 (11.1)1 (4.2)
Infection of secondary wound, n (%)1 (5.6)2 (8.3)
Acute bronchitis, n (%)1 (5.6)0 (0)
Injury (twisted ankle, humerus fracture due to fall), n (%)2 (11.1)0 (0)
Hospitalization for pre-existing condition¶, n (%)0 (0)1 (4.2)
  • Total n is smaller for some outcomes due to drop-outs and some missing data at week 10.

  • *Fisher’s exact probability test.

  • †Mann-Whitney U test.

  • ‡A negative value implies an increase in wound surface area.

  • §A lower score implies a better wound state.

  • ¶Benign prostate hyperplasia.