A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns.

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). Secondary endpoints included confirmed wound closure (WC) at Week 12, durable WC at Week 24, time to WC, scar evaluation, and wound infection-related events. RESULTS: Fifty-two patients with 96 treatment sites were enrolled. Pruritus was the most common TEAE (22 patients [42.3 %]). Twenty serious TEAEs occurred in 10 patients (19.2 %); none were related to StrataGraft. There were 4 (7.7 %) deaths (aspiration, myocardial infarction, self-injury, Gram-negative rod sepsis); none were related to StrataGraft. Confirmed WC was achieved by Week 12 in 33 patients (63.5 %; 95 % CI: 50.4-76.5 %) and 69 treatment sites (71.9 %; 95 % CI: 62.9-80.9 %). Durable WC was achieved by Week 24 in 29 patients (55.8 %; 95 % CI: 42.3-69.3 %) and 58 treatment sites (60.4 %; 95 % CI: 50.6-70.2 %). CONCLUSIONS: StrataGraft demonstrated clinical benefit. Safety data were consistent with previously reported findings.

Holistic View of Autografting Patients by Percentage of Total Body Surface Area Burned: Medical Record Abstraction Integrated with Administrative Claims.

Aim: This retrospective observational study provides a holistic view of the clinical and economic characteristics of inpatient treatment of patients with thermal burns undergoing autografting, by integrating real-world data (RWD) from medical records from healthcare providers (HCPs) and administrative claims. Methods: We identified eligible patients between July 1, 2010, and November 30, 2019, from the HealthCore Integrated Research Database® (HIRD®) and obtained their medical records from HCPs. We abstracted data from medical records to describe patient demographics and clinical characteristics and obtained costs of treatment from claims. Results: Two hundred patients were stratified into cohorts based on the percentage of total body surface area (%TBSA) burned: minor (< 10%), moderate (10%-24%), and major (≥ 25%). Data obtained from medical records and administrative claims were comparable to previous findings from administrative claims data. This privately insured study cohort predominantly consisted of White men. Diabetes mellitus and hypertension were frequently reported in a relatively young population. Key clinical characteristics that could influence burn treatment decisions and long-term outcomes, such as body mass index, size of autograft donor site, and mesh ratio, were frequently underdocumented in patients' medical records. Conclusion: Evidence generated from 2 orthogonal RWD sources confirmed that patients with larger %TBSA burned required more intensive care, thereby incurring higher costs. This study highlights considerable incompleteness in many critical fields in medical records, which limits the ability to generate broader insights. More comprehensive documentation of clinical characteristics and outcomes of autografts and donor sites in the operative and medical notes is critical to appropriately evaluate their impact on outcomes of burn treatments in future research using RWD.

Pooled safety analysis of STRATA2011 and STRATA2016 clinical trials evaluating the use of StrataGraft® in patients with deep partial-thickness thermal burns.

OBJECTIVE: This analysis includes pooled safety data from 2 clinical trials (NCT01437852; NCT03005106) that evaluated the safety and efficacy of StrataGraft in patients with deep partial-thickness (DPT) burns. METHODS: The study enrolled 101 adult patients with thermal burns covering 3-49% of total body surface area. Patients were followed for up to 1 year. The pooled safety events included: adverse events (AEs), adverse reactions (ARs), serious AEs (SAEs), discontinuation, and deaths; immunological responses (reactivity to panel reactive antibodies [PRA] and human leukocyte antigen [HLA] class 1 alleles); and persistence of allogeneic DNA from StrataGraft. RESULTS: Eighty-seven (86.1%) patients experienced 397 AEs. Thirty patients (29.7%) experienced ARs; 16 patients (15.8%) experienced SAEs. The most frequent AEs were pruritus (n = 31; 30.7%), and blister, hypertension, and hypertrophic scar (n = 11 each; 10.9%); the most common AR was pruritus (n = 13; 12.9%). One patient discontinued the study; 2 patients experienced SAEs (unrelated to StrataGraft) leading to death. PRA and HLA allele reactivity was ≤ 25% at Month 3, with no persistent allogeneic DNA from StrataGraft. CONCLUSIONS: StrataGraft was well tolerated by patients, with a safety profile similar to autograft. StrataGraft may offer a safe alternative to autograft for DPT burns.

Split-thickness skin graft donor-site morbidity: A systematic literature review.

The purpose of this systematic literature review is to critically evaluate split-thickness skin graft (STSG) donor-site morbidities. The search of peer-reviewed articles in three databases from January 2009 to July 2019 identified 4271 English-language publications reporting STSG donor-site clinical outcomes, complications, or quality of life. Of these studies, 77 met inclusion criteria for analysis. Mean time to donor-site epithelialization ranged from 4.7 to 35.0 days. Mean pain scores (0-10 scale) ranged from 1.24 to 6.38 on postoperative Day 3. Mean scar scores (0-13 scale) ranged from 0 to 10.9 at Year 1. One study reported 28% of patients had donor-site scar hypertrophy at 8 years. Infection rates were generally low but ranged from 0 to 56%. Less frequently reported outcomes included pruritus, wound exudation, and esthetic dissatisfaction. Donor-site wounds underwent days of wound care and were frequently associated with pain and scarring. Widespread variations were noted in STSG donor-site outcomes likely due to inconsistencies in the definition of outcomes and utilization of various assessment tools. Understanding the true burden of donor sites may drive innovative treatments that would reduce the use of STSGs and address the associated morbidities.

Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft.

UNLABELLED: While randomized controlled trials (RCTs) are designed to evaluate efficacy and/or safety under controlled conditions, use of strict inclusion/ exclusion criteria are noted to exclude more than 50% of wound populations. Applicability of RCT outcomes to performance expectations in real-world wound populations raises questions about generalizing their results. The primary aim of this decellularized, dehydrated human amniotic membrane (DDHAM) Use Registry Study was to gain experience and observe outcomes with use of a DDHAM in uninfected, full-thickness, or partial-thickness wounds that, in the investigators' opinions, would benefit from such treatment. METHODS: Investigators were instructed to provide usual care regarding visit and application frequencies, concomitant therapies, and change in wound-care regimens. The only exclusions were patients with actively infected wounds or known hypersensitivity to DDHAM. Fifteen sites with practicing wound care clinicians of various specialties participated in this review, enrolling chronic wounds including venous, diabetic, pressure, collagen vascular, and arterial ulcers-all of various severities, durations, sizes, and previous treatments. Twenty-eight ulcers studied had failed 32 previous treatments with advanced biologic therapies. A total of 244 wounds were observed in this study, however, this review is limited to the 179 chronic wounds in 165 patients that were enrolled at 15 of the 19 participating centers. The 4 centers that enrolled acute wounds only were excluded. RESULTS: Results from the analysis of this very heterogeneous population demonstrated that during the usual course of an average of 8 weeks of wound management, patients experienced factors that significantly affected wound closure. These factors included wound infections, noncompliance with prescribed treatments (eg, compression, off-loading, and wound care), re-injury of the wound, and systemic comorbidities. Nearly 50% of chronic wounds (including those that failed previous therapy with advanced biologics) with an average baseline area of 3.1 cm2 achieved complete closure within a median of 6.3 weeks without product-related adverse experiences. CONCLUSION: Despite the challenges of uncontrolled factors that affect healing, this registry study demonstrated the safety and clinical benefit of DDHAM to support wound closure across a variety of chronic wound types and patient conditions in real-world environments.