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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier:
NCT01594385
First received: January 5, 2012
Last updated: April 24, 2017
Last verified: April 2017
  Purpose

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.

Condition Intervention
Open Abdomen Abdominal Adhesions Trauma Wounds and Injury Biological: Seprafilm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)

Resource links provided by NLM:


Further study details as provided by Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 and the Functional Outcome Measures during the available follow-up period.

  • 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


Enrollment: 30
Study Start Date: April 2010
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Seprafilm
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

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.
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.

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

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594385

Locations
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
Sponsors and Collaborators
Stan Stawicki
Investigators
Principal Investigator: Stanislaw P Stawicki, MD Ohio State University
  More Information

Publications:
Responsible Party: Stan Stawicki, Associate Professor of Surgery, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT01594385     History of Changes
Other Study ID Numbers: 2009H0311
Study First Received: January 5, 2012
Results First Received: May 10, 2014
Last Updated: April 24, 2017
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania:
Open Abdomen
Damage Control
Trauma
Wound healing
Gun shot wounds
Stab wounds
Automobile accidents
Wounds and Injury

Additional relevant MeSH terms:
Wounds and Injuries
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 17, 2017