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

• 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: Stan Stawicki
• Information provided by (Responsible Party): Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Open Abdomen; Abdominal Adhesions; Trauma; Wounds and Injury	Biological: Seprafilm	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• 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)
• Study Start Date: April 2010
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

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 Outcome Measures:

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

   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
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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• 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

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 of Results:

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.

• Responsible Party: Stan Stawicki, Associate Professor of Surgery, St. Luke's Hospital and Health Network, Pennsylvania
• ClinicalTrials.gov Identifier: NCT01594385
• Other Study ID Numbers: 2009H0311
• First Posted: May 9, 2012
• Results First Posted: May 30, 2017
• Last Update Posted: November 20, 2017
• Last Verified: October 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:

Tissue Adhesions; Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes