This article discusses StrataGraft, a bioengineered skin substitute, as an alternative to autografting for severe deep partial-thickness (DPT) burns. Autografting, the current standard, involves taking healthy skin from the patient to cover burn wounds, which can cause pain, infection risk, scarring, and limitations, especially for older or thin-skinned patients. The safety and efficacy of StrataGraft has been evaluated and reported through several RCTs, including a Phase 1b study (STRATA2011) and a Phase 3 study (STRATA2016). In STRATA2011, 30 DPT burn patients treated with StrataGraft required no autografting by Day 28. Additionally, 93% of patients achieved wound closure by Month 3, a rate comparable to autograft closure. STRATA2016 further confirmed StrataGraft's safety and effectiveness in 71 patients, showing that it reduced or eliminated the need for autografting while producing treatment-emergent adverse events (TEAEs) consistent with those commonly observed in burn patients. The following literature review focuses on the StrataCAT study, a Phase 3b, open-label, single-arm, multicenter, expanded-access trial that further evaluated the safety and clinical outcomes of StrataGraft. This study aimed to provide continued access to StrataGraft for patients, while increasing clinical experience with the product and further assessing its effectiveness.
In StrataCAT, 52 adult patients with moderate to extensive burns (3%–50% TBSA) were treated with a single application of StrataGraft. Patients were monitored for 24 weeks. Most participants (88.5%) experienced at least one TEAE, the most common being mild pruritus. There were 20 serious TEAEs in 10 patients (19.2 %), none of which were attributed to StrataGraft. There were four deaths (7.7%) due to unrelated causes (aspiration, myocardial infarction, self-injury, Gram-negative rod sepsis). StrataGraft was effective in wound healing, with 88.5% of patients achieving complete wound closure without the need for additional autografting. By Week 12, 33 patients (63.5%) had achieved wound closure, and 29 patients (55.8%) showed durable closure by Week 24. Only six patients (11%) required partial autografting due to incomplete healing at certain sites. Scar assessments showed stable scores, with patients and observers reporting satisfactory outcomes. Certain study limitations must be acknowledged. First, the study design did not include a comparator arm and was neither designed nor powered to determine efficacy. Second, the sample size was not racially or ethnically diverse enough to understand scar outcomes based on skin type. And finally, COVID-19 restrictions hindered data collection for in-person observer scoring. Nonetheless, the authors concluded that StrataGraft can be used safely and has clinical benefits in a real-world population of adult patients with DPT burns with intact dermal elements. The use of StrataGraft in patients with DPT burns was donor-site sparing and the benefit-to-risk balance for using StrataGraft to treat adults with DPT burns demonstrated favorability. Further studies with larger study cohorts are needed to confirm these findings, evaluate efficacy, and assess the use of StrataGraft in patients with a larger TBSA burned.
Autologous skin cell suspension (ASCS) has recently been introduced as a point-of-care device to be used for immediate application on burn wounds. A small and thin piece of donor skin is only needed and can provide a 1:80 expansion ratio, resulting in utilization of smaller donor skin compared to standard of care. A standard contact layer dressing (CLD) is included in the device kit and utilized as an immediate cover dressing over the ASCS, but may have issues with adherence, fluid accumulation and infection. Poly-lactic acid dressings (PLAD) are a biosynthetic burn dressing designed to mimic the properties of human epithelium by acting as a barrier and adhering closely to the wound bed. PLAD have a microporous structure which prevents the buildup of exudate and minimizes post burn infections. In this work, the authors describe their experience transitioning from CLD to PLAD with either ASCS alone, or after a combination treatment of ASCS and split thickness skin grafts (STSG). Primary outcomes were length of stay (LOS) and wound infection. Secondary outcomes included number of surgical procedures, duration of antibiotics, and total adjusted charges per %TBSA. To examine this, the authors conducted a single-center retrospective cohort study of all patients admitted to their institution from January 2019 to October 2022, sustained 10% TBSA or greater burns, and were surgically treated with excision and grafting with ASCS. From January 2019 to 2021, patients were treated with ASCS combined with CLD, and afterwards were treated with ASCS combined with PLAD. Grafting was performed with either ASCS only or ASCS and STSG at the discretion of the operating surgeon.
Over the four-year period, 71 patients were included for study, of which 28 patients received the CLD dressing and 43 received PLAD. Mean % TBSA was 22.5%. ASCS + STSG was performed in 25 (89%) CLD and 34 (79%) PLAD patients (p = 0.34) and mean area grafted (3641 cm2) was comparable between groups (p = 0.99). Mean overall LOS was 22 days and CLD patients had significantly longer LOS compared to PLAD patients (29 vs 17 days, p = 0.0079). In univariate analyses, significant predictors of LOS were dressing group (p = 0.002), use of STSG (p < 0.0001), total area grafted (p < 0.0001), age (p = 0.053), having a comorbidity (p = 0.04), and % TBSA (p < 0.0001). In multivariate analyses, use of PLAD was significantly associated with a deceased LOS. Postoperative infections were higher in the CLD vs PLAD patients (39% vs 9%, p = 0.006). Duration of antibiotic therapy was also longer in CLD compared to PLAD patients (4.39 vs 0.47 days, p = 0.0074). In univariate analyses, significant predictors of having a post-operative infection were dressing group (p = 0.011), total area grafted (p = 0.019), and %TBSA (p = 0.01). In multivariate analyses, the use of PLAD was significantly associated with a decreased infection. Absolute mean charges were higher in the control patients ($737,839 vs $494,447), which was not significant. (p = 0.1235). When charges were adjusted for inflation and calculated based on % TBSA, this trended toward significance with decreased charges in the PLAD group ($25,396 vs $18,459, p = 0.0621). The authors suggest that the features of the PLAD dressing – close adherence to the wound, barrier function against outside infection and fluid egress, and its similar structure to the native dermal bed – may play a role in these findings. The authors conclude that the use of PLAD with ASCS resulted in decreased postoperative infection rates, hospital length of stay, and number of surgeries when compared to a retrospective cohort in which CLD with was utilized. In addition, decreased patient charges were also noted.
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