OBJECTIVES: Using data from a national wound-specific electronic medical record (WoundExpert®, Net Health, Pittsburgh, PA), we compared the effectiveness of a bilayered living cellular construct (BLCC) and an acellular fetal bovine collagen dressing (FBCD) for the treatment of venous leg ulcers (VLUs).

METHODS: Data from 1,021 patients with 1,021 refractory venous leg ulcers (as defined by failure to have >40% reduction in size in the 4 weeks prior to treatment), with surface areas between 1 and 40 cm, treated at 177 wound care facilities across the US were analyzed.

RESULTS: Patient baseline demographics and wound characteristics were comparable between groups. Kaplan-Meier–derived estimates of wound closure for BLCC (893 wounds) was significantly greater (p = 0.01) by weeks 12 (31% vs. 25%), 24 (55% vs. 43%), and 36 (68% vs. 53%) respectively compared with FBCD (128 wounds). BLCC treatment reduced the median time to wound closure by 37%, achieving healing 11 weeks sooner (19 vs. 30 weeks, p = 0.01). Treatment with BLCC increased the probability of healing by 45% compared with FBCD dressing (Hazard Ratio = 1.45 [95% CI, 1.08, 1.94], p = 0.01). Analyses of two de-identified insurance claims databases showed that VLU treatment costs were directly proportional to the frequency of and time to healing. Medicare patients with non-healed VLUs had 78% more hospitalization days, 50% more emergency department visits, 27% more outpatient office visits, and 60% more days of home healthcare. Total healthcare costs were $537/week higher for patients with open VLUs.

CONCLUSIONS: In the current VLU comparative effectiveness analysis, the significant differences in both time to and frequency of healing suggest that BLCC may provide significant cost savings compared with FBCD.*

*De-identified patient data were HIPAA compliant. Net Health was not involved in any way in the analysis, interpretation, or reporting of the data.