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胸前植入物乳房重建围手术期并发症的真实世界数据:一项前瞻性队列研究。

Real-world data of perioperative complications in prepectoral implant-based breast reconstruction: a prospective cohort study.

作者信息

Hamann Moritz, Bensmann Elena, Andrulat Anne, Festl Jasmin, Saadat Gitti, Klein Evelyn, Chronas Dimitrios, Braun Michael

机构信息

Department of Gynecology, Breast Center, Red Cross Hospital, Taxisstr. 3, 80637, Munich, Germany.

Department of Gynecology and Obstetrics, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.

出版信息

Arch Gynecol Obstet. 2024 Dec;310(6):3077-3089. doi: 10.1007/s00404-024-07807-5. Epub 2024 Nov 7.

Abstract

PURPOSE

To analyze complications and potential risk factors associated with immediate prepectoral direct-to-implant breast reconstruction (DTIBR).

METHODS

295 patients (326 operated breasts) with DTIBR between March 2021 and December 2023 were included in this prospective study. Postoperative complications (postoperative bleeding, seroma, infection, necrosis, wound dehiscence, implant exchange/loss) were analyzed for potential risk factors by descriptive and logistic regression analyses.

RESULTS

The implant was covered by TiLOOP® Bra Pocket in 227 breasts (69.6%), by "dual-plane" technique in 20 breasts (6.1%), by acellular dermal matrix (ADM) in 1 breast (0.3%). No additional support was used for 78 breasts (23.9%). The use of mesh did not increase the risk for complications. Major complications requiring surgical revision occurred due to postoperative bleeding in 22 (6.7%), seroma in 2 (0.6%), infection in 13 (4.0%), necrosis in 10 (3.1%), and wound dehiscence in 10 (3.1%) breasts. Thirteen (4.0%) implants were exchanged, and 5 (1.5%) were explanted without substitution. One patient had to switch to autologous reconstruction due to skin necrosis. The main reasons for the removal/exchange of implants were infections (11 breasts, 3.4%) and necrosis (4 breasts, 1.2%). The risk for necrosis, infection, and wound dehiscence was mainly associated with the type of incision, especially skin-reducing incisions, and body mass index (BMI) ≥ 30 kg/m.

CONCLUSION

Severe complications occurred primarily in patients with a BMI ≥ 30 kg/m and when skin-reducing surgical techniques were performed.

TRIAL REGISTRY

This study was retrospectively registered at the German Clinical Trials Register (DRKS) on 20.06.2024.

DRKS-ID: DRKS00034493. https://drks.de/search/de/trial/DRKS00034493 .

摘要

目的

分析即刻胸前区直接植入式乳房重建术(DTIBR)相关的并发症及潜在风险因素。

方法

本前瞻性研究纳入了2021年3月至2023年12月期间接受DTIBR的295例患者(326侧手术乳房)。通过描述性分析和逻辑回归分析对术后并发症(术后出血、血清肿、感染、坏死、伤口裂开、植入物更换/丢失)的潜在风险因素进行分析。

结果

227侧乳房(69.6%)采用TiLOOP®胸罩口袋覆盖植入物,20侧乳房(6.1%)采用“双平面”技术,1侧乳房(0.3%)采用脱细胞真皮基质(ADM)。78侧乳房(23.9%)未使用额外支撑。使用网片并未增加并发症风险。因术后出血导致22侧乳房(6.7%)发生需要手术翻修的严重并发症,血清肿导致2侧乳房(0.6%),感染导致13侧乳房(4.0%),坏死导致10侧乳房(3.1%),伤口裂开导致10侧乳房(3.1%)。13侧乳房(4.0%)更换了植入物,5侧乳房(1.5%)取出植入物未进行替换。1例患者因皮肤坏死不得不改为自体乳房重建。植入物取出/更换的主要原因是感染(11侧乳房,3.4%)和坏死(4侧乳房,1.2%)。坏死、感染和伤口裂开的风险主要与切口类型有关,尤其是皮肤缩减切口,以及体重指数(BMI)≥30kg/m²。

结论

严重并发症主要发生在BMI≥30kg/m²的患者以及采用皮肤缩减手术技术时。

试验注册

本研究于2024年6月20日在德国临床试验注册中心(DRKS)进行回顾性注册。

DRKS编号:DRKS00034493。https://drks.de/search/de/trial/DRKS00034493

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