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临床试验/NCT01594385
NCT01594385已完成不适用

Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)

Stan Stawicki10 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
10
主要终点
Adhesion Characteristics

研究概览

简要总结

The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:

  • the number and intensity of adhesions,
  • whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,
  • rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and
  • whether there is any difference between treatment groups regarding patient functional recovery.

详细描述

Data to be analyzed includes:

Age, gender, traumatic injuries, trauma alert level, procedure information, length of hospital stay, length of ICU stay, interval between admission and initial operation, interval between operations, whether operation took place during the day or night, duration of operation in minutes, number of surgeons present during the operation, description of the initial operation, justification for using damage control approach, complications noted, injuries missed or delayed in diagnosis, Acute Physiology and Chronic Health Evaluation II (APACHE II) calculations at various time points, Simplified Acute Physiology Score (SAPS II) calculations at various time points, Glasgow Coma Score (GCS) calculations at various time points, changes in GCS at over time, Injury Severity Score (ISS) at various time points, Abbreviated Injury Scale (AIS) at various time points, Penetrating Abdominal Trauma Index score (if applicable) at various time points, complete blood count (CBC) results at various time points, blood chemistry results at various time points, blood gas results at various time points, subject randomization information, number of operations, adhesion scores (Zuhlke and Yaacobi) for each operative procedure, contamination score for each operative procedure, diagnosis and description of sub-procedures for each operative procedure, wound characteristics from the start and end of all operative procedures (e.g. length and width of the fascia and skin), type of abdominal coverage or closure, discharge destination (e.g. home, short term rehabilitation facility, etc.), Functional Outcome Measure score, Glasgow Outcome Score (GOS) at various time points, number and interval of post discharge follow-up visits, wound characteristics since discharge at several time points and complications/complaints noted since discharge at several time points.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Trauma patients undergoing DC/OA management for traumatic injury
  • Life expectancy longer than 48 hours

排除标准

  • Prisoners
  • Pregnant patients
  • Younger than 18 years of age

研究组 & 干预措施

Seprafilm

Other

The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio.

干预措施: Seprafilm (Biological)

No Seprafilm

No Intervention

This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.

结局指标

主要结局

Adhesion Characteristics

时间窗: Up to 1 year

Zuhlke adhesion score (1 - minimum to 4 - maximum) 1. = filmy adhesions, easy to separate by blunt dissection 2. = stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization 3. = strong adhesions; lysis possible by sharp dissection only; clear vascularization 4. = very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable

次要结局

  • Wound Healing Characteristics(Participants will be followed until their open abdomen is closed. Depending on the nature and severity of the wound, this period may last as long as 1 year after the patient has been discharged.)

研究者

发起方
Stan Stawicki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stan Stawicki

Associate Professor of Surgery

St. Luke's Hospital and Health Network, Pennsylvania

研究点 (10)

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