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临床试验/NCT02436083
NCT02436083已完成4 期

The Value of Perioperative Antibiotics on the Success of Oral Free Flap Reconstructions

Technical University of Munich0 个研究点目标入组 350 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
350
主要终点
Frequencies of wound infection detected by clinical examinations (daily for 2 weeks, 2 times per week afterwards)

研究概览

简要总结

The purpose of this study is to monitor and compare peri-operative problems and outcomes of reconstructive surgery with microvascular free flaps in the head and neck region between groups of patients treated with perioperative antibiotics and a group of patients without antibiotics.

详细描述

Study Design and Patient Recruitment All clinical investigations have been conducted according to the principles expressed in the Declaration of Helsinki. Patient consent was written. Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps was eligible. Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history were not included in this study as the protocols available are not comparable in doses and effect on the irradiated tissue.14 A prospective study was initiated from July of 2007 to June 2012. All patients were prospectively evaluated.

Postoperative Care The investigators standard regimen was to keep the patient sedated for one night on the intensive care unit and then transfer to the surgical ward. The specific intravenous antibiotic therapy was started 30 minutes before the operation and administered for 10 days.

Data Analysis Recorded parameters included: age, sex, preoperative medical history, American society of Anesthesiologists classification of preoperative status 15, diagnosis, stage of disease, defect localisation, type of microvascular free flap, choice of recipient vessels, flap success, rate and number of operative revisions, primary or secondary reconstruction, type of previous treatment (radiation or surgery), type of previous neck dissection (if any), microvascular complications, the total operative time, wound healing disturbances subdivided into dehiscence and infection at the neck, region of reconstruction, or donor site, and prophylactic antibiotic agent, if used. Infection was defined as a purulent discharge at the wounds.

Descriptive statistics for quantitative variables are given as the mean ± standard deviation. The data were analyzed with the "Statistical Package for the Social Sciences" software (IBM® SPSS® Statistics for Windows, Version 22.0; IBM Corp., Armonk, NY, USA). Figures are generated with SPSS and Microsoft® Office Excel (Microsoft Excel for Windows, release 11.0, 2003, Microsoft Corporation, Redmond, WA, USA). Multiple linear regression analyses were used to determine factors independently associated with the dependent variable wound infection or wound healing disturbances. 95% confidence intervals (95% CI) are also given. Differences were considered to be statistically significant for a two-sided p-value of less than 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps.

排除标准

  • Healthy humans.
  • Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history.

研究组 & 干预措施

experimental group

Active Comparator

drug administration (antibiotic)

干预措施: antibiotic (use of penicilline, unacid, cefuroxime) (Drug)

结局指标

主要结局

Frequencies of wound infection detected by clinical examinations (daily for 2 weeks, 2 times per week afterwards)

时间窗: participants will be followed for the duration of hospital stay (2 weeks) and a total of 12 weeks

次要结局

未报告次要终点

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

thomas.muecke

responsible consultant

Technical University of Munich

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