TABLE 10.
Incidence rates of subjects experiencing wound complications
| Wound complications in per‐protocol population | Treatment group | ||
|---|---|---|---|
| NPWTi‐d (n = 71) | NPWT (n = 66) | P‐value Fisher's exact test | |
| Yes | 28 (39.4%) | 21 (31.8%) | |
| No | 43 (60.6%) | 45 (68.2%) | .38 |
| MedDRAa System Organ Class | Treatment group | ||
| Treatment‐related complications by system organ class for safety population | NPWTi‐d (n = 93) | NPWT (n = 88) | |
| Subjects experiencing at least 1 treatment‐related complication | 20 (21.5%) | 11 (12.5%) | |
| Skin and subcutaneous tissue disorders (skin maceration, rash, and dermatitis) | 18 (19.4%) | 9 (10.2%) | |
| General disorders and administration site conditions (pain and necrosis) | 3 (3.2%) | 1 (1.1%) | |
| Injury, poisoning, and procedural complications (blister, wound complication, and wound dehiscence) | 1 (1.1%) | 2 (2.3%) | |
| Infections and infestations (purulent discharge) | 1 (1.1%) | 0 (0.0%) | |
Abbreviations: NPWT, negative‐pressure wound therapy; NPWTi‐d, NPWT with cyclical instillation and a period of dwell.
a
MedDRA version 13.0.