Real-World Comparative Effectiveness Assessment Study of a Native Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial and a Cryopreserved Cadaveric Skin Allograft for Use in Diabetic Foot Ulcers - A Non-inferiority Analysis.

Objective: To determine the effectiveness of a native type I collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) and a cryopreserved cadaveric skin allograft (CCSA) for use in diabetic foot ulcers (DFUs). Methods: A real-world data study was conducted on 989 DFUs analyzed digitally. Of these, 325 and 664 DFUs were treated with PCMP and CCSA, respectively. Non-inferiority testing for equivalence of PCMP and CCSA was performed at a level of significance of P < .05. Results: Cox proportional hazards regression analysis for healing for PCMP and CCSA at weeks 4, 8, 12, and 24 was 12% vs 10%, 27% vs 24%, 39 % vs 37%, and 60% vs. 64%, respectively. No statistically significant differences were shown; P = .95. The median time to healing was 18 and 17 weeks for PCMP and CCSA, respectively; P = .95. The probability of healing was statistically equivalent between PCMP and CCSA; hazard ratio = 0.99; 95% CI (0.85, 1.17). Non-inferiority statistical testing results showed P = .01. Conclusions: Using non-inferiority hypothesis testing at a level of significance of P <.05, we showed that PCMP was equivalent to CCSA; P = .01. PCMP vs CCSA demonstrated no statistically significant differences in median time, percentage, and probability of healing. Data from real-world data comparative effectiveness assessment studies can help guide clinicians to limit overuse of ineffective therapies and underuse of effective therapies.

Real-world data analysis of bilayered living cellular construct and fetal bovine collagen dressing treatment for pressure injuries: a comparative effectiveness study.

Aim: To determine the effectiveness of bilayered living cellular construct (BLCC) versus a fetal bovine collagen dressing (FBCD) in pressure injuries (PRIs). Methods: A real-world data study was conducted on 1352 PRIs analyzed digitally. 1046 and 306 PRIs were treated with BLCC and FBCD, respectively. Results: Cox healing for BLCC (n = 1046) was significantly greater (p < 0.0001) at week 4 (13 vs 7%), 8 (29 vs 17%), 12 (42 vs 27%), 24 (64 vs 45%), and 36 (73 vs 56%). The probability of healing increased by 66%, (hazard ratio = 1.66 [95% CI (1.38, 2.00)]; p < 0.0001. Time to healing was 162 days for FBCD and 103 days for BLCC showing a 36% reduction in time to healing with BLCC; (p < 0.0001). Conclusion: BLCC significantly improved healing of PRIs versus FBCD.