Marie Brown-Etris1, Catherine T Milne2, Jason P Hodde3. 1. Etris Associates, Inc, 14450 Bustleton Avenue, Philadephia, PA, 19116, USA. Electronic address: mbeetris@aol.com. 2. Connecticut Clinical Nursing Associates, LLC, 204 Keegan Rd, Plymouth, CT, 06782, USA. Electronic address: ccna2@juno.com. 3. Cook Biotech Incorporated, 1425 Innovation Place, West Lafayette, IN, 47906, USA. Electronic address: Jason.Hodde@cookbiotech.com.
Abstract
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.
RCT Entities:
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.
Authors: William A Marston; John C Lantis; Stephanie C Wu; Aksone Nouvong; Tommy D Lee; Nicholas D McCoy; Herbert B Slade; Scheffer C Tseng Journal: Wound Repair Regen Date: 2019-08-19 Impact factor: 3.617
Authors: Wasima Oualla-Bachiri; Ana Fernández-González; María I Quiñones-Vico; Salvador Arias-Santiago Journal: Int J Mol Sci Date: 2020-11-02 Impact factor: 5.923