Stephen-Haynes Jackie, Stephens Claire
Practice Development Unit, Birmingham City University and Worcestershire Health & Care Trust, Worcestershire, UK.
Practice Development Unit, Birmingham City University and Worcestershire Health & Care Trust, Worcestershire, UKBirmingham City University and Worcestershire Health & Care Trust, Worcestershire, UK.
Int Wound J. 2013 Dec;10(6):689-96. doi: 10.1111/j.1742-481X.2012.01045.x. Epub 2012 Jul 27.
The study involves 95 subjects within a UK Primary Care Organisation and was undertaken in two arms. The objective was to determine the clinical outcomes and clinical acceptability of a newly available range of no-sting barrier film and no-sting barrier cream products offering significant financial benefits. The importance of undertaking this study is underpinned by evidence in the literature relating to the use of no-sting barrier preparations within clinical practice. The first part of the study (arm 1) involved extensive evaluation of either the film or cream barrier in 36 patients and was compared to existing standardised barrier protection care within the organisation. The results indicated that the new product range met all the criteria for formulary inclusion and following this the barrier range was further evaluated in arm 2, 33 patients with barrier cream and 26 patients with barrier film. The entire study was conducted over a 3-month period with patient treatment lasting a minimum of 2 days to a maximum 4-week period adhering to the agreed evaluation protocol as approved by clinical governance. In arm 1 (n = 36), the clinical expectation of the product was met in 32 cases relating to ease of use, conformability, no-sting, quick drying, ease of absorption, compatibility with devices, frequency of application, prevention and management including visual skin improvement resulting in a recommendation for formulary listing in 31 of 36 cases. In arm 2 (n = 59), barrier film and barrier cream performance was consistently rated same as, better than or much better than the existing barrier used. A formulary listing recommendation was made in 51 of 59 cases.
该研究涉及英国一家初级医疗保健机构的95名受试者,分为两个组进行。目的是确定一系列新推出的无刺痛屏障膜和无刺痛屏障乳膏产品的临床效果和临床可接受性,这些产品具有显著的经济效益。开展这项研究的重要性得到了文献中有关在临床实践中使用无刺痛屏障制剂的证据的支持。研究的第一部分(第1组)对36名患者的屏障膜或屏障乳膏进行了广泛评估,并与该机构现有的标准化屏障保护护理进行了比较。结果表明,新产品系列符合纳入药品目录的所有标准,在此之后,在第2组对屏障产品系列进行了进一步评估,其中33名患者使用屏障乳膏,26名患者使用屏障膜。整个研究在3个月内进行,患者治疗时间最短为2天,最长为4周,遵循临床治理批准的商定评估方案。在第1组(n = 36)中,32例患者对产品的临床期望得到满足,涉及易用性、贴合性、无刺痛、干燥快、吸收容易、与器械的兼容性、使用频率、预防和管理,包括皮肤外观改善,因此36例中有31例建议列入药品目录。在第2组(n = 59)中,屏障膜和屏障乳膏的性能一直被评为与现有屏障相同、优于或远优于现有屏障。59例中有51例建议列入药品目录。