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Incidence of the Most Common* Adverse Events
| Apligraf® (n=112) | Control (n=96) | |
|---|---|---|
| At the Study Ulcer Site | ||
| Suspected wound infection | 12 (10.7%) | 13 (13.5%) |
| Cellulitis | 10 (8.9%) | 8 (8.3%) |
| Osteomyelitis | 3 (2.7%) | 10 (10.4%) |
| Not at the Study Ulcer Site | ||
| Neuropathic ulcer† | 19 (17.0%) | 9 (9.4%) |
| Suspected wound infection | 15 (13.4%) | 7 (7.3%) |
| Nonneuropathic skin alteration‡ | 13 (11.6%) | 11 (11.5%) |
| Cellulitis | 11 (9.8%) | 4 (4.2%) |
| Osteomyelitis | 10 (8.9%) | 3 (3.1%) |
| Peripheral edema | 4 (3.6%) | 11 (11.5%) |
*Occurring in 10 or more patients.
†New ulceration.
‡Ulcer skin (erosions, fissures, lacerations, excoriations, and abrasions).
Additional safety parameters (hospitalizations, sepsis, life-threatening adverse events, and death) were comparable.
At sites other than the study ulcer, a total of 84 and 48 wound-related adverse events occurred in the Apligraf and control groups, respectively.
The Use of Apligraf is Supported by Experience
Well tolerated in over 80,000 patient applications.1
Reference:
¹Data on file at Organogenesis Inc.