一项SSI预防有关的研究方案，这是预印本吗？
Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trialAbstract
Background
Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization,costs and even mortality and remain one of the most frequent surgical complications.Approximately 14% to 30% of all patients undergoing elective open abdominal surgery are affected and methods to reduce surgical site infection rates warrant further investigation and evaluation in randomized controlled trials.
Methods/design
To investigate whether the application of a circular plastic wound protector reduces the rate of surgical site infections in general and visceral surgical patients that undergo midline or transverse laparotomy by 50%. BaFO is a randomized, controlled, patient-blinded and observer-blinded multicenter clinical trial with two parallel surgical groups. The primary outcome measure will be the rate of surgical site infections within 45 days postoperative assessed according to the definition of the Center for Disease Control. Statistical analysis of the primary endpoint will be based on the intention-to-treat population. The global level of
significance is set at 5% (2 sided) and sample size (n = 258 per group) is determined to assure a power of 80% with a planned interim analysis for the primary endpoint after the inclusion of 340 patients.
Discussion
The BaFO trial will explore if the rate of surgical site infections can be reduced by a single, simple, inexpensive intervention in patients undergoing open elective abdominal surgery. Its pragmatic design guarantees high external validity and clinical relevance.
Trial registration
http://www.clinicaltrials.gov NCT01181206. Date of registration: 11 August 2010; date of first patient randomized: 8 September 2010.
今天邮箱里收到这篇文章的信息，仔细看来是一个研究方案，貌似准备接受发表了。我国有这种形式吗？高手能否指导一下这种形式的来龙去脉？
一般如果您是某杂志的审稿专家的话，就会在文章发表之前请您审核，您需要提出意见和建议，多名专家涵审合格后才能发表。不知道您这个属不属于我说的这种情况。 楚楚老师：
您好！
就这个问题，我了解一点，与您分享。
一些临床随机对照试验登记后，可能发表一篇protocal，类似于考克兰在做循证研究的protocal。
详细的列出自己的研究思路和干预计划：采样点，样本量，干预措施等等信息。这个也是可以发表在SCI期刊的，如impliment SCI,等。这里是没有结果的。这类杂志有专门接受随机对照试验的protcol版块。
然后等真正试验结束后再将结果文章总结。发表到相应的杂志上。
我国这方面还没有实现，国外一般都是这样的。他们所有的临床试验都要register。
我也只是有些皮毛的理解，希望对您略微有些帮助。
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