Most chronic wounds are related to comorbidities, for which no clinical trials are performed. This retrospective propensity matched-cohort study examined data from 2 074 000 lower extremity wounds across 644 institutions to determine the effectiveness of TheraSkin plus standard of care (SOC; n = 1997) versus SOC alone (n = 1997). Multivariate modelling comparing outcomes such as healing rates, percent area reductions (PARs), amputations, recidivism, treatment completion, and medical transfers were evaluated. A higher proportion of wounds in the treatment group compared with the controls were more likely to close (68.3% versus 60.3%), particularly wounds with exposed structures (64% versus 50.4%) and with lower recidivism at 6 months (24.9% versus 28.3%). The control group was 2.75x more likely to require amputation than the treatment group. The combination of propensity matching and logistic regression analysis on a particularly large database demonstrated that wounds treated with TheraSkin had higher healing rates, higher PARs (78.7% versus 68.9%), fewer amputations, lower recidivism, higher treatment completion (61.0% versus 50.6%), and lower medical transfers (16.1% versus 23.5%) than SOC alone. This study considered data from complex wounds typically excluded from controlled trials and supports the idea that real-world evidence studies can be valid and reliable.
This retrospective, matched‐cohort study analyzed 1,556 patients with diabetic ulcers treated at 470 wound centers throughout the United States to determine the effectiveness of a cryopreserved bioactive split‐thickness skin allograft plus standard of care when compared to standard of care alone. There were 778 patients treated with the graft in the treatment cohort, who were paired with 778 patients drawn from a pool of 126,864 candidates treated with standard of care alone (controls), by using propensity matching to create nearly identical cohorts. Both cohorts received standard wound care, including surgical debridement, moist wound care, and offloading. Logistic regression analysis of healing rates according to wound size, wound location, wound duration, volume reduction, exposed deep structures, and Wagner grade was performed. Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. Diabetic ulcers were 59% more likely to close in the treatment cohort compared to the control cohort (p = 0.0045). The healing rate with the graft was better than standard of care across multiple subsets, but the most significant improvement was noted in the worst wounds that had a duration of 90‐179 days prior to treatment (p = 0.0073), exposed deep structures (p = 0.036), and/or Wagner Grade 4 ulcers (p = 0.04). Furthermore, the decrease in recidivism was statistically significant at 3 months, 6 months, and 1 year, with and without initially exposed deep structures (p < 0.05). The amputation rate in the treatment cohort was 41.7% less than that of the control cohort at 20 weeks (0.9% vs. 1.5%, respectively). This study demonstrated that diabetic ulcers treated with a cryopreserved bioactive split‐thickness skin allograft were more likely to heal and remain closed compared to ulcers treated with standard of care alone.
Data collected from standardized clinical practices can be valuable in evaluating the real-world therapeutic benefit of skin substitutes in the treatment of venous leg ulcers (VLU). Utilizing such a dataset, this study aimed to validate the effectiveness of a bioactive human split-thickness skin allograft for the treatment of VLU in the real-world setting and to understand how certain variables impacted healing rates. From a pool of 1474 VLU treated with allograft, 862 ulcers in 742 patients were selected from a large wound EMR database and analyzed. All patients received standard wound care prior to allograft application. Impact of ulcer duration, number of applications, ulcer size, and time to application were analyzed. The VLU, on average, were of 189 days duration with a mean ulcer size of 19.3 cm 2. During treatment, 70.7% of wounds healed, with an average time to closure of 15 weeks (SD = 14.1 weeks). The percentage of VLU less than one-year duration that healed was significantly higher (72.3%) than the percentage of VLU with duration of greater than 1 years (51.5%) (χ 2 = 18.17; P < .001). Ulcers less than 10 cm 2 in size were more likely to heal (73.9%) than those larger than 10 cm 2 (67.9%) (χ 2 = 8.65,P = .03). VLU receiving allograft within 90 days of initial presentation are 1.4 times more likely to heal vs those receiving their first BSA application after 90 days of standard of care (95% CI: [1.05, 1.86], P = .02). Allograft used in wound clinics healed a majority of refractory VLU, even in large ulcers of long duration, which are more difficult to heal. Smaller wound, size, and shorter wound duration were associated with greater likelihood of healing. VLUs treated earlier with allograft had better healing outcomes. Clinicians may consider more aggressive and timely treatment with allograft for refractory VLU.
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