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It is uncertain whether hydrocolloid dressings, a more costly intervention than offering standard care with petrolatum, is superior to prevent pressure ulcers among hospitalized high-risk adults. Randomized, parallel-group, open-label, superiority trial with an active control group, blinded for investigators, event validators, and analysts (December 1, 2015 to December 12, 2017). Eligible patients were ≥ 18 years of age with intact skin judged as high-risk for skin ulcers (Braden scale), admitted to surgical or medical wards of two tertiary-level hospitals. Participants were randomized (1:1) to protection with hydrocolloid dressings or petrolatum. The primary outcome was the first occurrence of pressure ulcers (with post-injury photographs adjudicated by three judges) under intention-to-treat analysis. Based on prior cost analysis, and the available resources (assumed incidence of 6 ulcers/1000 patient-days in controls), inclusion of up to 1500 participants allowed to surpass a one-sided superiority threshold > 5% based on a target efficacy > 40% for dressings. We planned an economic analysis using a decision tree model based on the effectiveness of the study results from a perspective of the third payer of health care. After inclusion of 689 patients (69 events), the trial was stopped for futility after a planned interim analysis (conditional power < 0.1 for all scenarios if the trial was completed). Pressure ulcers had occurred in 34 (10.2%) patients in the intervention group [9.6 per 1000 patient-days] and 35 (9.9%) participants in the control group [7.9 per 1000 patient-days], HR = 1.07 [95% CI 0.67 to 1.71]. The estimated incremental cost for dressings (a dominated strategy) was USD 52.11 per patient. Using hydrocolloid dressings was found similar to petrolatum for preventing pressure ulcers among hospitalized high-risk patients. As it conveys additional costs, and in this study was unlikely to demonstrate enough superiority, this strategy did not overcome conventional skin care.Trial registration: ClinicalTrials.gov identifier (NCT number): NCT02565745 registered on December 1, 2015.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10703794 | PMC |
http://dx.doi.org/10.1038/s41598-023-47483-0 | DOI Listing |
Cochrane Database Syst Rev
December 2024
School of Nursing & Midwifery, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin, Ireland.
Br J Nurs
November 2024
Senior Lecturer, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, aby.
The increasing incidence of surgical site infections (SSIs) following caesarean sections highlights the necessity for updated protocols that address risk factors throughout the preoperative, intraoperative, and postoperative stages. Negative Pressure Wound Therapy (NPWT) and hydrocolloid dressings have demonstrated potential for improving wound management and reducing complications, particularly by enhancing dressing integrity. Nevertheless, the application of NPWT requires careful consideration and adherence to local trust guidelines to ensure both its safety and efficacy.
View Article and Find Full Text PDFArch Craniofac Surg
October 2024
Department of Plastic and Reconstructive Surgery, Wonkwang University Hospital, Iksan, Korea.
Background: Wound healing is a complex process influenced by a variety of environmental factors. Dressing materials play a critical role in creating barriers against contaminants, maintaining optimal moisture levels, and absorbing wound exudate. Therefore, selecting materials tailored to wound characteristics is crucial for enhancing outcomes.
View Article and Find Full Text PDFBiomed Mater
November 2024
Medical Information College, Chongqing Medical University, Chongqing 400016, People's Republic of China.
As the incidence of chronic wounds increases, the requirements for wound dressings are rising. The specific aim of this study is to propose a novel gallic acid (GA) functionalized silk fibroin (SF) and gelatin (Gel) composite wound dressing in which GA is used as an antibacterial and wound healing substance. Via electrospinning, SF, Gel, and GA mixed solutions could be conveniently fabricated into a composite nanofiber mat (SF-Gel-GA), consisting of uniform fibers with an average diameter around 134.
View Article and Find Full Text PDFInt J Biol Macromol
November 2024
Hubei Key Laboratory of Polymer Materials, Key Laboratory for the Green Preparation and Application of Functional Materials (Ministry of Education), Hubei Collaborative Innovation Center for Advanced Organic Chemical Materials, School of Materials Science and Engineering, Hubei University, Wuhan 430062, China. Electronic address:
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