Clinical trial NCT01594385: Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients
Official title: Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Abdomen
Abdominal Adhesions
Trauma
Wounds and Injury
Keywords: Open Abdomen
Damage Control
Trauma
Wound healing
Gun shot wounds
Stab wounds
Automobile accidents
Wounds and Injury
Lead sponsor: St. Luke's Hospital and Health Network, Pennsylvania
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adhesion Characteristics
timeFrame: Up to 1 year
Secondary outcomes:
measure: Wound Healing Characteristics
timeFrame: 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.
Other outcomes:
measure: Patient Mortality
timeFrame: 28 days & end of follow-up
measure: Enterocutaneous and Other Fistula
timeFrame: Up to 1 year post-injury
measure: Ventral Hernia
timeFrame: Up to 1 year follow-up
measure: Infection / Abscess / Sepsis
timeFrame: Up to 1 year
measure: Bowel Obstruction
timeFrame: Up to 1 year follow-up
measure: Patient Functional Outcomes
timeFrame: Up to 1 year follow-up
measure: Would Complication
timeFrame: Up to 1 year follow-up period
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Ohio State University
name: Stanislaw P Stawicki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.