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脱细胞真皮基质作为吊带试验的乳房重建评估(BREASTrial):一项前瞻性随机试验的设计与方法

The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial.

作者信息

Agarwal Jayant P, Mendenhall Shaun D, Anderson Layla A, Ying Jian, Boucher Kenneth M, Liu Ting, Neumayer Leigh A

机构信息

Salt Lake City, Utah; and Springfield, Ill. From the Division of Plastic and Reconstructive Surgery, the Department of Surgery, the Division of Epidemiology, Department of Internal Medicine, and the Department of Pathology, University of Utah School of Medicine; and the Institute for Plastic Surgery, Southern Illinois University School of Medicine.

出版信息

Plast Reconstr Surg. 2015 Jan;135(1):20e-28e. doi: 10.1097/PRS.0000000000000809.

DOI:10.1097/PRS.0000000000000809
PMID:25539330
Abstract

BACKGROUND

Recent literature has focused on the advantages and disadvantages of using acellular dermal matrix in breast reconstruction. Many of the reported data are from low level-of-evidence studies, leaving many questions incompletely answered. The present randomized trial provides high-level data on the incidence and severity of complications in acellular dermal matrix breast reconstruction between two commonly used types of acellular dermal matrix.

METHODS

A prospective randomized trial was conducted to compare outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix. The impact of body mass index, smoking, diabetes, mastectomy type, radiation therapy, and chemotherapy on outcomes was analyzed. Acellular dermal matrix biointegration was analyzed clinically and histologically. Patient satisfaction was assessed by means of preoperative and postoperative surveys. Logistic regression models were used to identify predictors of complications.

RESULTS

This article reports on the study design, surgical technique, patient characteristics, and preoperative survey results, with outcomes data in a separate report. After 2.5 years, we successfully enrolled and randomized 128 patients (199 breasts). The majority of patients were healthy nonsmokers, with 41 percent of patients receiving radiation therapy and 49 percent receiving chemotherapy. Half of the mastectomies were prophylactic, with nipple-sparing mastectomy common in both cancer and prophylactic cases. Preoperative survey results indicate that patients were satisfied with their premastectomy breast reconstruction education.

CONCLUSION

Results from the Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial will assist plastic surgeons in making evidence-based decisions regarding acellular dermal matrix-assisted tissue expander breast reconstruction.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

摘要

背景

近期文献聚焦于在乳房重建中使用脱细胞真皮基质的利弊。许多报道的数据来自低证据水平的研究,使得诸多问题未得到充分解答。本随机试验提供了关于两种常用脱细胞真皮基质在脱细胞真皮基质乳房重建中并发症发生率和严重程度的高级别数据。

方法

进行一项前瞻性随机试验,比较使用AlloDerm或DermaMatrix进行即刻分期组织扩张器乳房重建的结果。分析体重指数、吸烟、糖尿病、乳房切除术类型、放射治疗和化疗对结果的影响。对脱细胞真皮基质的生物整合进行临床和组织学分析。通过术前和术后调查评估患者满意度。使用逻辑回归模型确定并发症的预测因素。

结果

本文报告研究设计、手术技术、患者特征和术前调查结果,结果数据在另一篇报告中呈现。2.5年后,我们成功招募并随机分配了128例患者(199个乳房)。大多数患者是健康的非吸烟者,41%的患者接受放射治疗,49%的患者接受化疗。一半的乳房切除术是预防性的,保乳乳房切除术在癌症和预防性病例中都很常见。术前调查结果表明患者对其乳房切除术前乳房重建教育感到满意。

结论

使用脱细胞真皮基质作为吊带进行乳房重建评估试验的结果将有助于整形外科医生就脱细胞真皮基质辅助组织扩张器乳房重建做出基于证据的决策。

临床问题/证据水平:治疗性,II级

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