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评估负压伤口治疗与乳腺手术标准护理敷料对比的随机对照试验:一项初步研究

Randomized Controlled Trial to Assess Negative Pressure Wound Therapy versus Standard-of-care Dressings in Breast Surgery: A Pilot Study.

作者信息

Chow Oliver, Graham Susannah, Ricciardello Daniel, Davies Matthew, Lajevardi Sepehr, Hussain Gazi, Deva Anand K

机构信息

From the Plastic and Reconstructive Surgery Department, Macquarie University Hospital, Sydney, New South Wales, Australia.

出版信息

Plast Reconstr Surg Glob Open. 2024 Jul 17;12(7):e5799. doi: 10.1097/GOX.0000000000005799. eCollection 2024 Jul.

DOI:10.1097/GOX.0000000000005799
PMID:39022530
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11254104/
Abstract

BACKGROUND

Standard breast reduction dressings such as Prineo are used to cover surgical wounds, in combination with a binder or support bra. The Prevena Restor BellaForm is a negative pressure wound therapy dressing that covers the entirety of the breast mound and is purported to provide further support and reduce swelling. The aim of this study was to compare the Restor to standard-of-care dressings.

METHODS

The study was a randomized control trial of women undergoing bilateral breast reduction with one breast being dressed with the Prevena Restor BellaForm dressing and the other having standard of care (Prineo). Outcomes measured were drain outputs, postoperative length of stay, quality of scarring, patient preference for dressings, and adverse events. Follow-up was at 1, 2-6, and 26 weeks.

RESULTS

The results show a reduction in postoperative days 1 and 2 average drain output on the Restor side compared with standard dressings. Patient-reported outcome measures showed less bruising. There was no difference in postoperative length of stay and no difference in appearance of scars at the 26-week follow-up period. One patient required removal of the dressing due to irritation and one patient required assistance with resealing of the vacuum.

CONCLUSIONS

We have shown benefits to drain output and comfort using close incisional negative pressure therapy in breast reduction mammaplasty. We plan to continue to investigate close incisional negative pressure therapy in larger comparative trials for other breast procedures including implant-based reconstruction, where a reduction in drain output could be of great benefit to both healing and reduction of infection risk.

摘要

背景

标准的乳房缩小术敷料,如Prineo,用于覆盖手术伤口,并与胸带或支撑胸罩配合使用。Prevena Restor BellaForm是一种负压伤口治疗敷料,可覆盖整个乳房隆起部位,据称能提供进一步的支撑并减轻肿胀。本研究的目的是将Restor与标准护理敷料进行比较。

方法

该研究是一项随机对照试验,对接受双侧乳房缩小术的女性进行研究,一侧乳房使用Prevena Restor BellaForm敷料,另一侧使用标准护理敷料(Prineo)。测量的结果包括引流液量、术后住院时间、瘢痕质量、患者对敷料的偏好以及不良事件。随访时间为1周、2 - 6周和26周。

结果

结果显示,与标准敷料相比,Restor侧术后第1天和第2天的平均引流液量有所减少。患者报告的结果指标显示瘀伤较少。术后住院时间没有差异,在26周随访期瘢痕外观也没有差异。一名患者因刺激需要移除敷料,一名患者需要协助重新密封负压装置。

结论

我们已经证明在乳房缩小整形术中使用切口负压封闭疗法对减少引流液量和舒适度有益。我们计划继续在更大规模的对照试验中研究切口负压封闭疗法在其他乳房手术中的应用,包括基于植入物的重建手术,在这些手术中减少引流液量可能对愈合和降低感染风险都有很大益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/feaa/11254104/b256dccb7cd2/gox-12-e5799-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/feaa/11254104/f02dd2f8893f/gox-12-e5799-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/feaa/11254104/a4564ac5c351/gox-12-e5799-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/feaa/11254104/b256dccb7cd2/gox-12-e5799-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/feaa/11254104/f02dd2f8893f/gox-12-e5799-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/feaa/11254104/a4564ac5c351/gox-12-e5799-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/feaa/11254104/b256dccb7cd2/gox-12-e5799-g003.jpg

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Plast Reconstr Surg. 2022 Mar 1;149(3):541-548. doi: 10.1097/PRS.0000000000008822.
2
Closed Incisional Negative Pressure Therapy Significantly Reduces Early Wound Dehiscence after Reduction Mammaplasty.闭合切口负压治疗显著降低缩乳术后早期伤口裂开发生率。
Plast Reconstr Surg Glob Open. 2021 Mar 22;9(3):e3496. doi: 10.1097/GOX.0000000000003496. eCollection 2021 Mar.
3
Outcomes of Breast Reduction Surgery Using the BREAST-Q: A Prospective Study and Comparison with Normative Data.
采用 BREAST-Q 进行乳房缩小手术的结果:一项前瞻性研究,并与标准数据进行比较。
Plast Reconstr Surg. 2019 Nov;144(5):1034-1044. doi: 10.1097/PRS.0000000000006114.
4
The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes.闭合切口负压疗法对乳房重建术后效果的影响。
Plast Reconstr Surg Glob Open. 2018 Aug 7;6(8):e1880. doi: 10.1097/GOX.0000000000001880. eCollection 2018 Aug.
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Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings.肿瘤性乳房手术中的闭合切口负压治疗:与标准护理敷料的比较。
Plast Reconstr Surg Glob Open. 2018 Jun 15;6(6):e1732. doi: 10.1097/GOX.0000000000001732. eCollection 2018 Jun.
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Reducing Infectious Complications in Implant Based Breast Reconstruction: Impact of Early Expansion and Prolonged Drain Use.减少基于植入物的乳房重建中的感染并发症:早期扩张和延长引流使用的影响。
Ann Plast Surg. 2016 Jun;76 Suppl 4:S312-5. doi: 10.1097/SAP.0000000000000760.
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