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Completed

NCT Number: NCT01594385

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

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.

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Key information

Conditions

Open Abdomen Abdominal Adhesions Trauma Wounds and Injuries Wounds and Injury Wounds, Penetrating Wounds, Stab

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cooper University Hospital, Camden, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seprafilm

Biological

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.

Primary outcomes

  1. Adhesion Characteristics

    Time frame: Up to 1 year

    Zuhlke adhesion score (1 - minimum to 4 - maximum)

    • = filmy adhesions, easy to separate by blunt dissection
    • = stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization
    • = strong adhesions; lysis possible by sharp dissection only; clear vascularization
    • = very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable

Secondary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. Ventral Hernia

    Time frame: Up to 1 year follow-up

    Determination of ventral hernia presence during follow-up visits

  4. Infection / Abscess / Sepsis

    Time frame: Up to 1 year

    Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods

  5. Bowel Obstruction

    Time frame: Up to 1 year follow-up

    Determination of bowel obstruction during the entire available study follow-up period

  6. 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

    • Fully dependent
    • Partially dependent
    • Independent w/device
    • Fully independent

    FOM Locomotion Subscale

    • Fully dependent
    • Partially dependent
    • Independent w/device
    • Fully independent

    FOM Expression/Communication Subscale

    • Fully dependent
    • Partially dependent
    • Independent w/device
    • Fully independent

    Glasgow Outcome Scale:

    • Death
    • Persistent vegetative state: Minimal responsiveness
    • Severe disability: Conscious but disabled; dependent on others for daily support
    • Moderate disability: Disabled but independent; can work in sheltered setting
    • Good recovery: Resumption of normal life despite minor deficits

  7. 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

Sponsors and collaborators

Lead sponsor

Stan Stawicki

Other

Registry information

Official study title

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

Acronym: OASIT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 9, 2012
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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