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

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ClinicalTrials.gov Identifier: NCT01594385
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : May 30, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania

Tracking Information
First Submitted Date  ICMJE January 5, 2012
First Posted Date  ICMJE May 9, 2012
Results First Submitted Date  ICMJE May 10, 2014
Results First Posted Date  ICMJE May 30, 2017
Last Update Posted Date November 20, 2017
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
Adhesion Characteristics [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
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. ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
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. ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 17, 2017)
  • Patient Mortality [ Time Frame: 28 days & end of follow-up ]
    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 ]
    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 ]
    Determination of ventral hernia presence during follow-up visits
  • Infection / Abscess / Sepsis [ Time Frame: Up to 1 year ]
    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 ]
    Determination of bowel obstruction during the entire available study follow-up period
  • Patient Functional Outcomes [ Time Frame: Up to 1 year follow-up ]
    Assessment of Glasgow Outcome Scale (GOS) and the Functional Outcome Measures (FOM) during the available follow-up period. FOM Source: [1] Ohio Dept of Public Safety. Ohio Trauma Registry Data Dictionary. Columbus: 2004. FOM Scale range: 1 (worst) to 4 (best); GOS Scale: 1 (worst) to 5 (best) FOM Feeding Subscale
    1. Fully dependent
    2. Partially dependent
    3. Independent w/device
    4. Fully independent
    FOM Locomotion Subscale
    1. Fully dependent
    2. Partially dependent
    3. Independent w/device
    4. Fully independent
    FOM Expression/Communication Subscale
    1. Fully dependent
    2. Partially dependent
    3. Independent w/device
    4. Fully independent
    Glasgow Outcome Scale:
    1. Death
    2. Persistent vegetative state: Minimal responsiveness
    3. Severe disability: Conscious but disabled; dependent on others for daily support
    4. Moderate disability: Disabled but independent; can work in sheltered setting
    5. Good recovery: Resumption of normal life despite minor deficits
  • Would Complication [ Time Frame: Up to 1 year follow-up period ]
    Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients
Official Title  ICMJE Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Open Abdomen
  • Abdominal Adhesions
  • Trauma
  • Wounds and Injury
Intervention  ICMJE Biological: 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.
Study Arms  ICMJE
  • Seprafilm
    The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio.
    Intervention: Biological: Seprafilm
  • No Intervention: No Seprafilm
    This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2012)
100
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594385
Other Study ID Numbers  ICMJE 2009H0311
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Currently, the only available data is de-identified dataset without any linkages to the original data. Data storage currently past record-keeping requirements. Study was permanently closed in June 2014.
Responsible Party Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania
Study Sponsor  ICMJE Stan Stawicki
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stanislaw P Stawicki, MD Ohio State University
PRS Account St. Luke's Hospital and Health Network, Pennsylvania
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP