Abstract
Objective
This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns.
Methods
Patients aged ≥18 years with 3–49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (≤2000 cm2 total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft. Coprimary endpoints were: the difference in percent area of StrataGraft treatment site and autograft treatment site autografted at Month 3 (M3), and the proportion of patients achieving durable wound closure of the StrataGraft site without autograft at M3. Safety assessments were performed in all patients. Efficacy and safety follow-up continued to 1 year.
Results
Seventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of StrataGraft treatment sites that required autografting, compared with autograft treatment sites (4.3% vs 102.1%, respectively; P < .0001). StrataGraft treatment resulted in durable wound closure at M3 without autografting in 92% (95% CI: 85.6, 98.8; n/n 59/64) of patients for whom data were available. The most common StrataGraft-related adverse event was pruritus (15%).
Conclusions
Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting.
Clinical Trial Identifier
NCT03005106.
【저자키워드】 good manufacturing practice, CIconfidence interval, confidence interval, SAESerious Adverse Event, Serious Adverse Event, Health Insurance Portability and Accountability Act, HIPAAHealth Insurance Portability and Accountability Act, BACCbioengineered allogeneic cellularized construct, bioengineered allogeneic cellularized construct, BSAbovine serum albumin, bovine serum albumin, CRFcase report form, case report form, DPTdeep partial-thickness, deep partial-thickness, FTfull-thickness, full-thickness, GMPGood Manufacturing Practice, HTShypertrophic scarring, hypertrophic scarring, ITTintent to treat, intent to treat, MImultiple imputation, multiple imputation, mITTmodified intent to treat, modified intent to treat, PRApanel reactive antibody, panel reactive antibody, POSASPatient and Observer Scar Assessment Scale, Patient and Observer Scar Assessment Scale, TBSAtotal body surface area, total body surface area, TEAEtreatment-emergent adverse event, treatment-emergent adverse event, 【초록키워드】 Treatment, Safety, Randomized, clinical, adverse event, Patient, Follow-up, assessment, patients, Burn, pruritus, Endpoint, Identifier, burns, offer, phase 3 study, objective, DPT, Result, enrolled, performed, proportion, evaluated, required, comparable, reduce, reduction in, Month, total body, 【제목키워드】 Open-label, Randomized, Patient, Efficacy and safety, Phase 3, Burn, Multicenter trial,