Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients (OASIT)
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.
Open Abdominal Wounds
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)|
- Wound healing characteristics [ Time Frame: 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. ] [ Designated as safety issue: No ]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.
- Adhesion characteristics [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Patients undergoing surgery in either arm of the study will be assessed for severity of intra-abdominal adhesions during each return trip to the operating room. Any patients taken back to the operating room for up to 1 year will be assessed for adhesion severity.
- Patient mortality [ Time Frame: 28 days & end of follow-up ] [ Designated as safety issue: No ]Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up)
- Enterocutaneous and other fistula [ Time Frame: Up to 1 year post-injury ] [ Designated as safety issue: Yes ]Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval
- Ventral hernia [ Time Frame: Up to 1 year follow-up ] [ Designated as safety issue: No ]Determination of ventral hernia presence during follow-up visits
- Infection / Abscess / Sepsis [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods
- Bowel obstruction [ Time Frame: Up to 1 year follow-up ] [ Designated as safety issue: No ]Determination of bowel obstruction during the entire available study follow-up period
- Patient functional outcomes [ Time Frame: Up to 1 year follow-up ] [ Designated as safety issue: No ]Assessment of Glasgow Outcome Scale and the Functional Outcome Measures during the available follow-up period.
- Would complication [ Time Frame: Up to 1 year follow-up period ] [ Designated as safety issue: No ]Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint
|Study Start Date:||April 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio.
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:
|No Intervention: No Seprafilm|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594385
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 32861|
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|St. Luke's Hospital|
|Bethlehem, Pennsylvania, United States, 18015|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Stanislaw P Stawicki, MD||Ohio State University|