1. Healing rate of hospital‐acquired skin tears using adhesive silicone foam versus meshed silicone interface dressings: A prospective, randomized, non‐inferiority pilot study.
- Author
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Fulbrook, Paul, Miles, Sandra J., and Williams, Damian M.
- Subjects
WOUND care ,SKIN injuries ,WOUND healing ,SILICONES ,RESEARCH funding ,T-test (Statistics) ,FOAMED materials ,STATISTICAL sampling ,PILOT projects ,CLINICAL trials ,FISHER exact test ,RANDOMIZED controlled trials ,HOSPITALS ,DESCRIPTIVE statistics ,CHI-squared test ,COMMERCIAL product evaluation ,LONGITUDINAL method ,ADHESIVES ,SURGICAL dressings ,COMPARATIVE studies ,DATA analysis software - Abstract
Background: A skin tear is a traumatic wound that occurs in up to one in five hospitalized patients. Nursing care includes application of a dressing to create a moist wound healing environment. Aim: To compare the effectiveness of two standard dressings (adhesive silicone foam vs. meshed silicone interface) to heal hospital‐acquired skin tear. Methods: An intention‐to‐treat pilot study was designed using a randomized, non‐inferiority trial in an Australian tertiary hospital setting. Consenting participants (n = 52) had acquired a skin tear within the previous 24 h and had agreed to a 3‐week follow‐up. Data were collected between 2014 and 2020. The primary outcome measure was wound healing at 21 days. Results: Baseline characteristics were similar in both arms. Per protocol, 86% of skin tears were fully healed at 3 weeks in the adhesive silicone foam group, compared to 59% in the meshed silicone interface group. Greater healing was observed across all skin tear categories in the adhesive silicone foam dressing group. In the intention‐to‐treat sample, healing was 69% and 42%, respectively. Conclusions: Results suggest the adhesive silicone foam dressing may be superior, as it produced clinically significant healing of skin tears at 3 weeks compared to the meshed silicone interface dressing. Accounting for potential loss to follow‐up, a sample of at least 103 participants per arm would be required to power a definitive study. Summary statement: What is already known about this topic? A skin tear is a traumatic wound that is commonly acquired during hospitalization that affects older adults in particular. In hospital settings, it may occur in up to one in five patients.A variety of skin tear dressings have been used in previous studies, with healing rates ranging from 34% to 97% at 21 days; however, evidence for the most effective dressing type is inconclusive.If treated inappropriately, or left untreated, minor skin tears can become chronic or complicated wounds, yet prevalence and treatment of hospital‐acquired injuries are under‐reported. What this paper adds? Based on our per‐protocol results, an adhesive silicone foam dressing may be superior, as it produced clinically significant healing of 86% of skin tears at 3 weeks compared to 59% with the meshed silicone interface dressing.Based on the methods and results from this pilot study, a future definitive trial would be feasible but would need to account for a relatively large loss to follow‐up rate. The implications of this paper: Using our intention‐to‐treat results, a future study would need a sample size of 103 per arm to be sufficiently powered, which may be impractical to achieve within a single hospital setting; thus, a multi‐site study would be advisable. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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