Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Open Abdomen, Abdominal Adhesions, Trauma, Wounds and Injury

Intervention / Treatment
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* Biological: Seprafilm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma patients undergoing DC/OA management for traumatic injury Age 18+ Life expectancy longer than 48 hours Exclusion Criteria: Prisoners Pregnant patients Younger than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Seprafilm<br>The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio. | Biological: Seprafilm<br>* 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.<br>|
| No Intervention: No Seprafilm<br>This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion Characteristics | Zuhlke adhesion score (1 - minimum to 4 - maximum) = filmy adhesions, easy to separate by blunt dissection = stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization = strong adhesions; lysis possible by sharp dissection only; clear vascularization = very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing Characteristics | There will not be a fixed duration of outpatient follow-up (fixed follow-up in trauma patients is not practical due to the unpredictable nature of trauma population), an average (mean) follow-up will be determined for the entire cohort of patients for the purposes of the study, up to a maximum of 1 year (if available) following hospital discharge. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Abdomen, Damage Control, Trauma, Wound healing, Gun shot wounds, Stab wounds, Automobile accidents, Wounds and Injury