SUBJECTS: All subjects were treated with open-celled reticulated foam (black foam) dressings. 78 subjects were treated with NPWT system K and 72 subjects were treated with system I in a long term acute care hospital (LTAC). Two hundred fifteen wounds were treated for a total of 4,756 NPWT days.
METHODOLOGY: Change in the Bates-Jensen Wound Assessment Tool (BWAT) score was used as the primary wound outcome measure for the NPWT systems applied to promote wound closure by secondary intention or to prepare wounds for delayed surgical closure. For these groups secondary wound outcome measures were change in wound size (length x width cm) and change in depth (cm). For patients where the NPWT systems were used to bolster skin substitutes or split thickness skin grafts the outcome measured was percent take of grafts.
RESULTS: Patient characteristics were similar in both groups except the I group had more patients on hemodialysis (p 0.035) and were more malnourished (p<0.001). A BWAT score change of 4 was pre chosen as indicative of a clinically significant change in the wound. Non inferiority of I to K NPWT systems was demonstrated, since the upper bound of the two-sided 95% confidence interval did not cross the non inferiority bound of 4. Additionally, NPWT system I provided a cost savings of $43,989.59 over a twelve month period. No statistical differences were found between the groups on the secondary outcomes of percent change in wound size, percent change in wound depth, and percent take of grafts.
CONCLUSION: NPWT system I provided a significant cost savings and was confirmed non-inferior to NPWT system K.