Head of the Nursing and Allied Profession Research Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Staff Nurse, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola - Malpighi, Bologna, Italy.
Int J Nurs Stud. 2022 Mar;127:104172. doi: 10.1016/j.ijnurstu.2022.104172. Epub 2022 Jan 8.
There is need for improvement in effective pressure ulcers preventive strategies.
To study whether a multi-layer silicone-adhesive polyurethane foam dressing shaped for the sacrum prevents PUs development in addition to standard PU preventive care for at-risk hospitalized patients.
Open-label, parallel group, multi-center randomized controlled trial.
709 in-hospital patients at risk for pressure ulcers from 25 medical, surgical, and intensive care units of 12 Italian hospitals.
A multi-layer silicone-adhesive polyurethane foam was applied to the sacrum in addition to standard PUs preventive care in the intervention group. In the control group, standard preventive care alone, including systematic pressure ulcer risk assessment, skin assessment three times per day, routine positioning every 4 h, use of active support surface as appropriate, and incontinence skin care, was guaranteed. Primary outcome was incidence of sacral pressure ulcers of any stage at seven days from hospital admission. Secondary outcomes were incidence of sacral pressure ulcers ≥ II stage, number of days needed to PU development, number of skin adverse events due to the foam dressing, number of dressings used for each patient, number of withdrawing patients due to discomfort caused by the foam dressing. Participants were evaluated at baseline and at seven days.
In patients admitted to medical units, 15/113 controls and 4/118 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 9.2%; NNT for benefit 11, 95% CI 6 to 44). In patients admitted to surgical units, 21/144 controls and 8/142 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 8.9%; NNT for benefit 11 95% CI 6 to 49). Pressure ulcers incidence was not significantly different between the randomization arms (5.2% experimental vs 10.4% control, p = 0.141) in patients admitted to intensive care units. Overall, 46/358 (12.8%) controls and 17/351 (4.8%) in the intervention group developed sacral pressure ulcers (p<0.001; absolute reduction 8%; number needed to treat (NNT) for benefit 12, 95% CI 8 to 26). Incidence of sacral pressure ulcers ≥ II stage did not differ significantly between the two groups. No adverse skin reactions and discomfort attributable to the foam application were reported.
A sacral multi-layer silicone-adhesive polyurethane foam in addition to standard preventive care is effective for pressure ulcers prevention in at-risk hospitalized patients admitted to medical and surgical units.
ClinicalTrials.gov NCT03900455. The registration (April 1st, 2019) occurred before the first patient was enrolled (October 21st, 2019).
需要改进有效的压疮预防策略。
研究多层硅酮粘合聚氨酯泡沫敷料是否能预防骶骨部位的压疮，同时预防高危住院患者的压疮。
开放性标签、平行组、多中心随机对照试验。
来自意大利 12 家医院的 25 个医疗、外科和重症监护病房的 709 名有压疮风险的住院患者。
在标准压疮预防护理的基础上，在干预组中对骶骨部位应用多层硅酮粘合聚氨酯泡沫敷料。在对照组中，仅提供标准预防护理，包括系统的压疮风险评估、每天三次皮肤评估、每 4 小时常规翻身、适当使用主动支撑面和失禁皮肤护理。主要结局是入院后 7 天发生任何阶段的骶骨压疮。次要结局包括骶骨压疮≥Ⅱ期的发生率、发生压疮的天数、因泡沫敷料引起的皮肤不良事件的数量、每位患者使用的敷料数量、因泡沫敷料引起的不适而退出的患者数量。参与者在基线和 7 天时进行评估。
在入住医疗病房的患者中，对照组有 15/113 人，干预组有 4/118 人发生骶骨压疮（p=0.010；绝对减少 9.2%；获益的 NNT 为 11，95%CI 为 6 至 44）。在入住外科病房的患者中，对照组有 21/144 人，干预组有 8/142 人发生骶骨压疮（p=0.010；绝对减少 8.9%；获益的 NNT 为 11，95%CI 为 6 至 49）。入住重症监护病房的患者中，两组之间的压疮发生率无显著差异（实验组为 5.2%，对照组为 10.4%，p=0.141）。总体而言，对照组有 46/358 人（12.8%），干预组有 17/351 人（4.8%）发生骶骨压疮（p<0.001；绝对减少 8%；获益的 NNT 为 12，95%CI 为 8 至 26）。骶骨压疮≥Ⅱ期的发生率在两组之间无显著差异。未报告因泡沫敷料应用引起的任何皮肤不良反应和不适。
在高危住院患者中，在标准预防护理的基础上应用多层硅酮粘合聚氨酯泡沫敷料可有效预防压疮，这些患者入住医疗和外科病房。
ClinicalTrials.gov NCT03900455。该注册（2019 年 4 月 1 日）发生在第一个患者入组之前（2019 年 10 月 21 日）。
