Table 6.

Study participants with amputations/resections and the number of amputations/resections performed in the ITT population

Amputations and resections in the ITT population	Total n=345	NPWT n=171	SMWC n=174	Difference (95% CI) p
Study participants with amputation or resection
n (%)  (95% CI)	71 (20.6%) (16.3−24.8)	35 (20.5%) (14.4 to 26.5)	36 (20.7%) (14.7−26.7)	1 (0.2%) (−19.0 − 18.6) 1.00 (F)
Total number of amputations and resections	102	45	57	12 0.89 (U)
Number of amputations and resections per study participant, n (%)
One event  Two events  Three events  Four events  Five events	49 (14.2%) 16 (4.6%) 4 (1.2%) 1 (0.3%) 1 (0.3%)	25 (14.6% 10 (5.8%) 0 (0% 0 (0%) 0 (0%)	24 (13.8%) 6 (3.4%) 4 (2.3%) 1 (0.6%) 1 (0.6%)	1 (0.8%) 4 (2.4%) 4 (2.3%) 1 (0.6%) 1 (0.6%)
Study participants with minor amputation	69 (20.0%)	33 (19.3%)	36 (20.7%)	3 (1.4%) 0.79 (F)
Study participants with major amputation	2 (0.6%)	2 (1.2%)	0 (0%)	2 (1.2%) 0.25 (F)

Data show the number (N) of participants, the percentage with the 95% CI, or the number of events accompanied with the respective percentage values in total and for both treatment arms.

F, Fishers' exact test; ITT, intention to treat; NPWT, negative pressure wound therapy; SMWC, standard moist wound care; U, Mann-Whitney U test.