Angélica Miguélez Chamorro1, M Clara Vidal Thomas2, Aina Soler Mieras3, Alfonso Leiva3, Martí Pons Martínez4, M Maria Soledad Hernández Yeste5. 1. Subdirector of "Atención a la Cronicidad, Coordinación Sociosanitaria, Salud Mental y Enfermedades poco frecuentes", Balearic Islands Health Service, Mallorca, Spain. 2. Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Mallorca, Spain; Balearic Islands Health Research Institute (IdISPA), Palma, Spain; Primary Care Preventive and Health Promotion Research Network (redIAPP), Spain. Electronic address: mcvidal@ibsalut.caib.es. 3. Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Mallorca, Spain; Balearic Islands Health Research Institute (IdISPA), Palma, Spain; Primary Care Preventive and Health Promotion Research Network (redIAPP), Spain. 4. Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Mallorca, Spain. 5. Rafal Nou Health Care Center, Pressure Ulcers Consultan from the Balearic Islands Health Service, Mallorca, Spain.
Abstract
BACKGROUND:Pressure ulcers are a major burden to patients because they affect health, well-being, and health-related quality of life. Thus, prevention and early treatment of pressure ulcers is a major challenge for health care professionals. OBJECTIVE: To compare the efficacy of hydrocellular and hydrocolloid dressings after 8 weeks of treatment of category II pressure ulcers. DESIGN: A prospective multicenter clinical trial with blinded outcome assessors. PARTICIPANTS AND SETTINGS: Adult patients with category II pressure ulcers from primary and long-term care institutions on Majorca island. METHODS:Category II ulcers were treated with ALLEVYN Adhesive® dressings or VARIHESIVE® GEL CONTROL dressings, with the primary outcome being healing of the ulcers in 8 weeks. Blinded confirmation of ulcer healing was performed by a treatment-group assessment committee. Estimates of cumulative survival probabilities were determined using the Kaplan-Meier method and analyses of effectiveness were performed using the chi-squared test. RESULTS: A total of 169 patients with pressure ulcers were enrolled, 84 of whom received hydrocellular dressings and 85 of whom receivedhydrocolloid dressings. A total of 58% were women and 56% were from primary care institutions. The hydrocellular dressing group had a higher percentage of healed pressure ulcers at 8 weeks (90.7% vs. 77.1%, p = 0.039) and a shorter average healing time (3 weeks vs. 4 weeks, p = 0.015). Analysis of safety outcomes at 8 weeks indicated that the hydrocellular dressing group had a smaller proportion of ulcers that were unhealed (3.9% vs. 7.1%) and a smaller proportion of ulcers that progressed to a higher category or infection (5.3% vs. 15.7%), although these differences were not statistically significant. CONCLUSIONS: This study of patients with category II pressure ulcers indicated that hydrocellular dressings were superior to hydrocolloid dressings in terms of healing at 8 weeks and time required for healing, although these two dressings had similar safety profiles.
RCT Entities:
BACKGROUND:Pressure ulcers are a major burden to patients because they affect health, well-being, and health-related quality of life. Thus, prevention and early treatment of pressure ulcers is a major challenge for health care professionals. OBJECTIVE: To compare the efficacy of hydrocellular and hydrocolloid dressings after 8 weeks of treatment of category II pressure ulcers. DESIGN: A prospective multicenter clinical trial with blinded outcome assessors. PARTICIPANTS AND SETTINGS: Adult patients with category II pressure ulcers from primary and long-term care institutions on Majorca island. METHODS: Category II ulcers were treated with ALLEVYN Adhesive® dressings or VARIHESIVE® GEL CONTROL dressings, with the primary outcome being healing of the ulcers in 8 weeks. Blinded confirmation of ulcer healing was performed by a treatment-group assessment committee. Estimates of cumulative survival probabilities were determined using the Kaplan-Meier method and analyses of effectiveness were performed using the chi-squared test. RESULTS: A total of 169 patients with pressure ulcers were enrolled, 84 of whom received hydrocellular dressings and 85 of whom received hydrocolloid dressings. A total of 58% were women and 56% were from primary care institutions. The hydrocellular dressing group had a higher percentage of healed pressure ulcers at 8 weeks (90.7% vs. 77.1%, p = 0.039) and a shorter average healing time (3 weeks vs. 4 weeks, p = 0.015). Analysis of safety outcomes at 8 weeks indicated that the hydrocellular dressing group had a smaller proportion of ulcers that were unhealed (3.9% vs. 7.1%) and a smaller proportion of ulcers that progressed to a higher category or infection (5.3% vs. 15.7%), although these differences were not statistically significant. CONCLUSIONS: This study of patients with category II pressure ulcers indicated that hydrocellular dressings were superior to hydrocolloid dressings in terms of healing at 8 weeks and time required for healing, although these two dressings had similar safety profiles.
Authors: Magdalena Sylwia Kamińska; Anna Maria Cybulska; Karolina Skonieczna-Żydecka; Katarzyna Augustyniuk; Elżbieta Grochans; Beata Karakiewicz Journal: Int J Environ Res Public Health Date: 2020-10-27 Impact factor: 3.390
Authors: Verónica Tiscar-González; Maria José Menor-Rodríguez; Carlos Rabadán-Sainz; Mercedes Fraile-Bravo; Tim Styche; Francisco José Valenzuela-Ocaña; Leticia Muñoz-García Journal: Adv Skin Wound Care Date: 2021-01 Impact factor: 2.373