UBM Displays Increased Rates of Healing with Stage 3 or 4 Pressure Injuries When Compared to Negative Pressure Wound Therapy

Objective: Management of pressure ulcers (PrU) with urinary bladder matrix (UBM) devices in comparison to management with negative pressure wound therapy (NPWT) is evaluated. It is hypothesized that the mean rate of healing will be superior with UBM alone compared to NPWT alone.

Criteria: Subjects meeting inclusion/exclusion criteria are enrolled, randomized, and treated with UBM or NPWT. NPWT is applied following manufacturer’s Instructions for Use. Follow-up is weekly through 12 weeks post-surgery, with evaluation at 13 and 26 weeks post-surgery. Offloading instructions were given to each subject.

Methods/Design: A total of 38 subjects were enrolled into both arms. Data are presented as UBM/NPWT. Enrollment was 19/19 subjects, and total number of treated wounds was 24/21. Baseline characteristics include age at consent (years): 60.9±16.9/70.0±15.7; gender (M:F): 13:6/10:9; wheelchair bound: 11/8 and avg. BMI: 26.67±5.95/24.12±6.01. Ratio of Stage 3:4 PrUs post-debridement was 3:21/4:17. Mean wound area (cm²) at randomization post-debridement was 25.74±18.78/25.87±18.12. Wounds in the UBM arm were predominantly located on the sacral and ischial areas, and wounds in the NWPT arm were predominantly located on the heel and foot areas.

Results: Thirty subjects with 34 wounds were evaluated at 13 weeks post-surgery. The mean rate of wound healing, measured by surface area (cm²/week) was -0.84±0.98/-0.26±1.55. Complete wound closure was seen in 2/0 wounds. In addition, 27 subjects with 31 wounds completed the 26 week follow-up. Complete wound closure was seen in 8/5 wounds. Periwound maceration was reported for 5/27 subjects. No procedure-related adverse events were observed. Statistical analysis will be completed with larger sample accrual.

Conclusions: Management of PrUs with UBM is trending to demonstrate a faster wound closure response when compared to NPWT.