Publications by authors named "Randi Rutan"

Purpose: To investigate the effect of StrataGraft (bioengineered allogeneic cellularized construct [BACC]) treatment on inpatient length of stay (LOS) as an indicator of hospital resource utilization.

Patients And Methods: Data from the single-arm StrataCAT trial for adult patients with deep partial-thickness (DPT) burns who received BACC were compared with data from a matched external control arm comprising patients who received autografting for burn treatment from the National Burn Repository (NBR) during the same time period as StrataCAT. A matching, quasi-experimental approach was used to investigate the cause-and-effect relationship between BACC treatment and LOS (days).

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Background: A phase 3b, open-label, multicenter, expanded-access study (NCT04123548) evaluated safety and clinical outcomes of StrataGraft treatment in adults with deep partial-thickness thermal burns with intact dermal elements.

Methods: Adult patients with 3 % to < 50 % total body surface area burns were treated with a single application of ≤ 1:1 meshed StrataGraft and followed for 24 weeks. Primary endpoint was count and percentage of patients with treatment-emergent adverse events (TEAEs).

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Article Synopsis
  • The analysis pooled safety data from two clinical trials (NCT01437852; NCT03005106) to evaluate StrataGraft's safety and efficacy in patients with deep partial-thickness burns.
  • A total of 101 adult patients were enrolled, with 86.1% experiencing adverse events; the most common were pruritus and blisters.
  • The study concluded that StrataGraft is well tolerated and presents a safety profile comparable to autografts, suggesting it may be a safe alternative for treating DPT burns.
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Unlabelled: Delayed closure of foot ulcers is a primary factor leading to lower extremity amputation in patients with diabetes, creating great demand for products or therapies to accelerate the rate of wound closure in this population. This study (ClinicalTrials.gov Identifier: NCT02209051) was designed to evaluate dehydrated amniotic membrane allograft (DAMA) (AMNIOEXCEL, Derma Sciences Inc, Princeton, NJ) plus standard of care (SOC) compared to SOC alone for the closure of chronic diabetic foot ulcers (DFUs).

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