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

Not Applicable

Completed

Conditions: Abdominal Adhesions
Trauma
Open Abdomen
Wounds and Injury

Interventions: Biological: Seprafilm

Registration Number: NCT01594385

Lead Sponsor: Stan Stawicki

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adhesion Characteristics	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

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (5): 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