A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns
Research article
[키워드] adverse event
assessment
BACCbioengineered allogeneic cellularized construct
bioengineered allogeneic cellularized construct
bovine serum albumin
BSAbovine serum albumin
Burn
burns
case report form
CIconfidence interval
clinical
comparable
confidence interval
CRFcase report form
deep partial-thickness
DPT
DPTdeep partial-thickness
Efficacy and safety
Endpoint
enrolled
evaluated
Follow-up
FTfull-thickness
full-thickness
GMPGood Manufacturing Practice
good manufacturing practice
Health Insurance Portability and Accountability Act
HIPAAHealth Insurance Portability and Accountability Act
HTShypertrophic scarring
hypertrophic scarring
Identifier
intent to treat
ITTintent to treat
MImultiple imputation
mITTmodified intent to treat
modified intent to treat
Month
Multicenter trial
multiple imputation
objective
offer
Open-label
panel reactive antibody
Patient
Patient and Observer Scar Assessment Scale
patients
performed
Phase 3
phase 3 study
POSASPatient and Observer Scar Assessment Scale
PRApanel reactive antibody
proportion
pruritus
Randomized
reduce
reduction in
required
Result
SAESerious Adverse Event
Safety
Serious Adverse Event
TBSAtotal body surface area
TEAEtreatment-emergent adverse event
total body
total body surface area
Treatment
treatment-emergent adverse event
[DOI] 10.1016/j.burns.2021.04.021 [Article Type] Research article
[DOI] 10.1016/j.burns.2021.04.021 [Article Type] Research article