[Corpitolinol 60预防手术患者压疮有效性的随机对照试验]

[Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in patients undergoing surgery].

作者信息

Chiari Paolo, Giorgi Sabina, Ugolini Daniela, Montanari Morena, Giudanella Pietro, Gramantieri Antonella, Collesi Franca, Pau Michelina, Smaldone Maddalena, Matarasso Maddalena, Mazzini Cinzia, Russo Francesca, Gazineo Domenica, Fontana Mirella, Taddia Patrizia

机构信息

Università di Bologna.

出版信息

Assist Inferm Ric. 2012 Jul-Sep;31(3):131-7. doi: 10.1702/1176.13039.

DOI:10.1702/1176.13039

PMID:23164965

Abstract

UNLABELLED

Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in surgical patients.

INTRODUCTION

The risk of pressure sores in surgical patients is widely recognised. The Corpitolinol 60 (Sanyréne®) applied on compressed areas seems to reduce the risk of pressure sores.

AIM

To assess the efficacy of Corpitolinol 60 in preventing pressure sores in the operatory theatre.

METHODS

The open label randomized clinical trial was conducted in 5 operating theatres of Northen Italy. Patients were randomized to receive Corpitolinol 60 in areas undergoing compression. Experimental group and controls were treated with usual measures for preventing pressure sores. The lesions were staged according to NPUAP up to 24 hours after surgery.

RESULTS

Three-hundred-one patients were randomized (155 in the Sanyréne® group and 143 controls). The main variables predictive of pressure sores risk (ASA class, sex, age, duration of the surgery, and BMI) were comparable across groups. At the end of the surgery 71 patients (23.8%) in the experimental group and 47 controls (30.8%) had a pressure sore (p 0.006; RR 1.81 IC95% 1.17-2.79). Twelve and 24 hours after surgery the differences between groups were not significant.

CONCLUSIONS

The aim of reducing pressure sores was not reached for patients treated with Corpitolinol 60.

摘要

未标注

关于Corpitolinol 60预防手术患者压疮有效性的随机对照试验。

引言

手术患者发生压疮的风险已得到广泛认可。在受压部位涂抹Corpitolinol 60（Sanyréne®）似乎可降低压疮风险。

目的

评估Corpitolinol 60在手术室预防压疮的疗效。

方法

在意大利北部的5个手术室进行了开放标签随机临床试验。患者被随机分配在受压部位使用Corpitolinol 60。实验组和对照组采用预防压疮的常规措施进行治疗。术后24小时内根据美国国家压疮咨询小组（NPUAP）的标准对损伤进行分期。

结果

301例患者被随机分组（Sanyréne®组155例，对照组143例）。预测压疮风险的主要变量（美国麻醉医师协会分级、性别、年龄、手术时长和体重指数）在各组间具有可比性。手术结束时，实验组有71例患者（23.8%）发生压疮，对照组有47例（30.8%）发生压疮（p = 0.006；相对危险度1.81，95%置信区间1.17 - 2.79）。术后12小时和24小时，两组间差异无统计学意义。