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抗菌敷料与标准敷料在肥胖行剖宫产妇女中的应用:一项随机对照试验。

Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial.

机构信息

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.

出版信息

Am J Perinatol. 2022 Jul;39(9):951-958. doi: 10.1055/s-0040-1721112. Epub 2020 Dec 2.

Abstract

OBJECTIVE

This study aimed to evaluate the effect of a novel antimicrobial dressing on patient satisfaction and health-related quality of life (HRQoL) following a cesarean delivery.

STUDY DESIGN

This was an open-label, single-center, two-arm randomized controlled trial. This study was done at the tertiary center, maternal unit, Galveston, TX. Pregnant women with body mass indices ≥35 kg/m2 were screened for eligibility. Women were randomized to ReliaTect Post-Op Dressing (RELIATECT) or standard wound dressing (STANDARD). Primary outcome was patient satisfaction and HRQoL using validated questionnaires. Secondary outcomes were provider satisfaction, surgical site infection (SSI) rates, and wound complications.

RESULTS

In total, 160 women were randomized. Population characteristics were not significant among groups. RELIATECT dressing group had an overall higher score of satisfaction and HRQoL compared with STANDARD group. Women in the RELIATECT group reported less incision odor and incisional pain. Compared with the STANDARD group, most women in RELIATECT dressing group reported better daily activities, self-esteem, personal hygiene, body image, and sleep. Providers reported that the RELIATECT dressing allowed better assessment of the surgical incision site, allowed patients to shower early, and did observe less wound dressing leakage. No differences were found in other secondary end points.

CONCLUSION

Postcesarean RELIATECT dressing for wound care in pregnant women with obesity had better patient and provider satisfaction as well as better HRQoL scores. Further, level 1 evidence is needed to assess its impact on SSI rates and wound complication, as this trial was not powered to accomplish this goal.

KEY POINTS

· This study was conducted to evaluate RELIATECT on patient satisfaction and HRQoL following a cesarean.. · Post-cesarean RELIATECT dressing for wound care had better HRQoL and patient and provider satisfaction scores.. · This is the first randomized controlled trial evaluating RELIATECT dressing in obese pregnant women undergoing cesarean section..

摘要

目的

本研究旨在评估一种新型抗菌敷料对剖宫产术后患者满意度和健康相关生活质量(HRQoL)的影响。

研究设计

这是一项开放性、单中心、双臂随机对照试验。该研究在得克萨斯州加尔维斯顿的三级中心、产妇单位进行。筛选出身体质量指数(BMI)≥35kg/m2 的孕妇,以评估其是否符合纳入标准。将这些孕妇随机分为 ReliaTect 术后敷贴(RELIATECT)组或标准伤口敷贴(STANDARD)组。主要结局是采用经过验证的问卷评估患者满意度和 HRQoL。次要结局包括提供者满意度、手术部位感染(SSI)发生率和伤口并发症。

结果

共有 160 名女性被随机分配。各组人群特征无显著差异。与 STANDARD 组相比,RELIATECT 敷贴组的满意度和 HRQoL 评分整体更高。RELIATECT 组的女性报告切口气味和切口疼痛较轻。与 STANDARD 组相比,RELIATECT 敷贴组的大多数女性报告在日常活动、自尊、个人卫生、身体形象和睡眠方面的情况更好。提供者报告称,RELIATECT 敷贴可更好地评估手术切口部位,允许患者更早淋浴,且观察到的伤口敷料渗漏较少。其他次要终点无差异。

结论

肥胖孕妇剖宫产术后使用 RELIATECT 进行伤口护理可提高患者和提供者满意度以及 HRQoL 评分。此外,还需要 1 级证据来评估其对 SSI 发生率和伤口并发症的影响,因为本试验的目的并非评估这些结局。

重点

· 本研究旨在评估 RELIATECT 在剖宫产术后患者满意度和 HRQoL 方面的作用。· 剖宫产术后使用 RELIATECT 敷贴进行伤口护理可提高 HRQoL 以及患者和提供者满意度评分。· 这是第一项评估 RELIATECT 敷贴在肥胖剖宫产孕妇中的随机对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef86/9325068/4287c87922cc/10-1055-s-0040-1721112-i200807-1.jpg

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