The safety profile of StrataGraft with regard to wound-related events* was similar to that of autograft treatment sites in clinical studies
Adverse reactions reported at a frequency of ≥2% (N=119) following treatment with StrataGraft® in 4 pooled trials1, †
*Including erythema, swelling, local warmth, and wound site infections.
†Safety data include patients enrolled in 4 randomized studies, including 2 clinical studies in patients with DPT thermal burns (STRATA2011 and STRATA2016) and 2 clinical studies in patients with full-thickness complex skin defects due to thermal burns or other causes.
‡If a patient had more than 1 incidence of an adverse reaction, the patient was counted only once.
StrataGraft is an effective, safe alternative to autograft for DPT burns
Based on clinical trial results:
- Overall, the safety profile of StrataGraft with regard to wound-related events was similar to that of autograft1
- No patients discontinued study participation due to adverse reactions1
- There have been no clinical reports of rejection reaction to StrataGraft1
- The wound infection rate was similar to autograft-treated sites (2 patients with treatment-emergent adverse events of infection in each treatment arm)1,2