Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients
NCT ID: NCT01594385
Last Updated: 2017-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2010-04-30
2013-12-31
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Seprafilm
The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio.
Seprafilm
Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:
* Two Seprafilm pieces between the liver and the anterior abdominal wall
* Four pieces over the exposed bowel surfaces anteriorly
* Two slightly staggered pieces of Seprafilm in each colic gutter
* Two pieces in the pelvic area.
* If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair.
No Seprafilm
This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
No interventions assigned to this group
Interventions
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Seprafilm
Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:
* Two Seprafilm pieces between the liver and the anterior abdominal wall
* Four pieces over the exposed bowel surfaces anteriorly
* Two slightly staggered pieces of Seprafilm in each colic gutter
* Two pieces in the pelvic area.
* If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair.
Eligibility Criteria
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Inclusion Criteria
* Age 18+
* Life expectancy longer than 48 hours
Exclusion Criteria
* Pregnant patients
* Younger than 18 years of age
18 Years
89 Years
ALL
No
Sponsors
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Stan Stawicki
OTHER
Responsible Party
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Stan Stawicki
Associate Professor of Surgery
Principal Investigators
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Stanislaw P Stawicki, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Cooper University Hospital
Camden, New Jersey, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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References
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Stawicki SP, Green JM, Martin ND, Green RH, Cipolla J, Seamon MJ, Eiferman DS, Evans DC, Hazelton JP, Cook CH, Steinberg SM; OPUS 12 Foundation, Inc, Multi-Center Trials Group & OASIT Investigators. Results of a prospective, randomized, controlled study of the use of carboxymethylcellulose sodium hyaluronate adhesion barrier in trauma open abdomens. Surgery. 2014 Aug;156(2):419-30. doi: 10.1016/j.surg.2014.03.007. Epub 2014 Mar 15.
Other Identifiers
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2009H0311
Identifier Type: -
Identifier Source: org_study_id