Showalter Brian M, Crantford J Clayton, Russell Gregory B, Marks Malcolm W, DeFranzo Anthony J, Thompson James T, Pestana Ivo A, David Lisa R
From the *Department of Plastic and Reconstructive Surgery, Wake Forest Baptist Health, Winston-Salem, NC; and †Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.
Ann Plast Surg. 2014;72(6):S165-9. doi: 10.1097/SAP.0000000000000086.
Clinical infection remains a significant problem in implant-based breast reconstruction and is a physical and emotional strain to the breast reconstruction patient. Bacterial strikethrough of draping and gown material is a likely source of infection. Strategies to reduce infection in implant-based breast reconstruction are essential to improve patient outcomes.
The aim of this study is to determine if a disposable draping system is superior to reusable draping materials in the prevention of implant-based breast reconstruction infection.
This single-institution, prospective, randomized, single-blinded, IRB-approved study enrolled women with breast cancer who were eligible for implant-based breast reconstruction. The primary endpoint was clinical infection by postoperative day 30. Secondary endpoints included all other complications encountered throughout the follow-up period and culture data. Demographic data recorded included patient age, body mass index, diabetes, smoking, chemotherapy, radiation, and follow-up. Procedural data recorded included procedure type, procedure length, estimated blood loss, use of acellular dermal matrix, use of muscle flap, and inpatient versus outpatient setting.
From March 2010 through January 2012, 107 women were randomized and 102 completed the study. Five patients were determined not to be candidates for reconstruction after randomization. There were 43 patients in the Reusable Group and 59 patients in the Disposable Group. There were no significant differences in patient demographic data, procedural data, or the type of procedure performed between groups. In the Reusable Group, there were 5 infections (12%) within 30 days compared to 0 (0%) infections in the Disposable Group (P = 0.012). There was no significant difference in secondary complications. There was a trend for positive wound cultures (11% vs. 3%, P = 0.10) and positive drape cultures (17% vs.4%, P = 0.08) in patients with clinical infection. There were no differences in the number of colony-forming units or positive cultures between groups.
Disposable draping material is superior to a reusable draping system in the prevention of clinical infection within the immediate postoperative period. This study did not demonstrate a clear link between intraoperative culture data and the development of clinical infection. A completely disposable gown and draping system is recommended during implant-based breast reconstruction.
临床感染在基于植入物的乳房重建中仍然是一个重大问题，对乳房重建患者来说是一种身体和情感上的负担。手术巾和手术衣材料的细菌穿透是感染的一个可能来源。减少基于植入物的乳房重建中感染的策略对于改善患者预后至关重要。
本研究的目的是确定一次性手术巾系统在预防基于植入物的乳房重建感染方面是否优于可重复使用的手术巾材料。
这项单机构、前瞻性、随机、单盲、经机构审查委员会批准的研究纳入了符合基于植入物的乳房重建条件的乳腺癌女性患者。主要终点是术后30天时的临床感染。次要终点包括随访期间遇到的所有其他并发症以及培养数据。记录的人口统计学数据包括患者年龄、体重指数（BMI）、糖尿病、吸烟情况、化疗、放疗及随访情况。记录的手术数据包括手术类型、手术时长、估计失血量、脱细胞真皮基质的使用、肌皮瓣的使用以及住院与门诊情况。
从2010年3月至2012年1月，107名女性被随机分组，102名完成了研究。5名患者在随机分组后被确定不适合进行重建。可重复使用组有43例患者，一次性使用组有59例患者。两组患者的人口统计学数据、手术数据或所进行的手术类型均无显著差异。在可重复使用组中，30天内有5例感染（12%），而一次性使用组为0例感染（0%）（P = 0.012）。次要并发症方面无显著差异。临床感染患者的伤口培养阳性（11%对3%，P = 0.10）和手术巾培养阳性（17%对4%，P = 0.08）有一定趋势。两组之间的菌落形成单位数量或培养阳性情况无差异。
一次性手术巾材料在预防术后早期临床感染方面优于可重复使用的手术巾系统。本研究未证明术中培养数据与临床感染发生之间存在明确联系。建议在基于植入物的乳房重建期间使用完全一次性的手术衣和手术巾系统。
