Aim: The purpose of the study was to evaluate clinical safety and effectiveness of Oasis® Wound Matrix as a treatment for full-thickness pressure ulcers and compare it to Standard Care.
Methods: A total of 130 adults with Stage III or Stage IV pressure ulcers were randomly assigned, received either multiple topical treatments of SIS plus standard care (n = 67), or standard care alone (n = 63), and were subsequently evaluated. Ulcer size was determined at enrollment and weekly throughout treatment. Healing was assessed at each visit for a period of up to 12 weeks, with incidence of complete healing and 90% reduction in ulcer area being the primary outcome measures.
Results: The proportion of complete healing in the SIS group was 40% as compared to 29% in the standard of care group (p = 0.111); the percentage of patients having a 90% reduction in ulcer surface area was 55% in the SIS group versus 38% in the standard of care group (p = 0.037).
Conclusions: The results of this study suggest that within the setting of a comprehensive wound care program, weekly treatment of chronic pressure ulcers with SIS wound matrix increases the incidence of 90% reduction in wound size versus standard of care alone.
Keywords: Decubitus ulcer; Extracellular matrix; Oasis wound matrix; Pressure injury; Pressure ulcer; SIS.
Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.