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

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

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Wounds and Injury; Open Abdomen; Abdominal Adhesions
• Intervention / Treatment: Biological: Seprafilm

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 32861
      • Carolinas Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesion Characteristics	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	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Characteristics	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Mortality	Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up)	28 days & end of follow-up
Enterocutaneous and Other Fistula	Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval	Up to 1 year post-injury
Ventral Hernia	Determination of ventral hernia presence during follow-up visits	Up to 1 year follow-up
Infection / Abscess / Sepsis	Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods	Up to 1 year
Bowel Obstruction	Determination of bowel obstruction during the entire available study follow-up period	Up to 1 year follow-up
Patient Functional Outcomes	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	Up to 1 year follow-up
Would Complication	Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint	Up to 1 year follow-up period

Collaborators and Investigators

• Sponsor: Stan Stawicki
• Investigators: Principal Investigator: Stanislaw P Stawicki, MD, Ohio State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: January 5, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (ESTIMATE): May 9, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Wound healing; Trauma; Open Abdomen; Damage Control; Gun shot wounds; Stab wounds; Automobile accidents; Wounds and Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Wounds and Injuries; Tissue Adhesions
• Other Study ID Numbers: 2009H0311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.