多中心随机对照试验比较水胶体泡沫敷料和水胶体敷料治疗初级和长期护理机构中 Ⅱ 期压力性溃疡的疗效和安全性。

Multicenter randomized controlled trial comparing the effectiveness and safety of hydrocellular and hydrocolloid dressings for treatment of category II pressure ulcers in patients at primary and long-term care institutions.

机构信息

Subdirector of "Atención a la Cronicidad, Coordinación Sociosanitaria, Salud Mental y Enfermedades poco frecuentes", Balearic Islands Health Service, Mallorca, Spain.

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.

出版信息

Int J Nurs Stud. 2019 Jun;94:179-185. doi: 10.1016/j.ijnurstu.2019.03.021. Epub 2019 Apr 4.

DOI:10.1016/j.ijnurstu.2019.03.021

PMID:31048187

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 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.

摘要

背景

压疮给患者带来了沉重负担，因为它们影响健康、幸福感和与健康相关的生活质量。因此，预防和早期治疗压疮是医疗保健专业人员面临的主要挑战。

目的

比较水胶体和水凝胶敷料在治疗 II 期压疮 8 周后的疗效。

设计

一项具有盲法结局评估员的前瞻性多中心临床试验。

参与者和设置

马略卡岛初级和长期护理机构的 II 期压疮成年患者。

方法

II 期溃疡采用 ALLEVYN 粘性敷料或 VARIHESIVE GEL CONTROL 敷料治疗，主要结局为 8 周内溃疡愈合。由治疗组评估委员会对溃疡愈合进行盲法确认。使用 Kaplan-Meier 法确定累积生存概率估计值，并使用卡方检验进行有效性分析。

结果

共纳入 169 例压疮患者，其中 84 例接受水胶体敷料治疗，85 例接受水凝胶敷料治疗。女性占 58%，初级保健机构患者占 56%。水胶体敷料组 8 周时愈合的压疮比例更高（90.7%比 77.1%，p=0.039），平均愈合时间更短（3 周比 4 周，p=0.015）。8 周时安全性结局分析表明，水胶体敷料组未愈合溃疡的比例更小（3.9%比 7.1%），溃疡进展为更高类别或感染的比例更小（5.3%比 15.7%），尽管这些差异无统计学意义。