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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seprafilm | Other | The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio. |
|
| No Seprafilm | No Intervention | This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion Characteristics | Zuhlke adhesion score (1 - minimum to 4 - maximum)
| Up to 1 year |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanislaw P Stawicki, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 | United States | ||
| Carolinas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24962185 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Seprafilm Group | Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation. |
| FG001 | No Seprafilm Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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
FOM Locomotion Subscale
FOM Expression/Communication Subscale
Glasgow Outcome Scale:
| 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 |
| Charlotte |
| North Carolina |
| 32861 |
| United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| St. Luke's Hospital | Bethlehem | Pennsylvania | 18015 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Seprafilm | The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in approximately 1:1 ratio. 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:
|
| BG001 | No Seprafilm | Patients in this group will not receive Seprafilm during re-operations. Otherwise, their surgical management will be identical to the Seprafilm Group. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adhesion Characteristics | Zuhlke adhesion score (1 - minimum to 4 - maximum)
| Posted | Mean | Standard Error | Scores on a scale | Up to 1 year | Zuhlke Adhesion Score | Zuhlke Adhesion Score |
|
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| Secondary | 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. | Wound areas for Seprafilm and "No Seprafilm" groups were obtained serially, by measuring each wound horizontally and vertically and multiplying measurements (in centimeters) to determine the estimated area in cm squared. | Posted | Mean | Standard Deviation | Square Centimeters (cm2) | 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. |
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| Other Pre-specified | Patient Mortality | Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up) | Note: Both mortalities in the Seprafilm group involved withdrawal of care as per previously stated patient wishes. | Posted | Number | Mortalities | 28 days & end of follow-up |
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| Other Pre-specified | Enterocutaneous and Other Fistula | Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval | Posted | Number | Total events | Up to 1 year post-injury |
|
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Ventral Hernia | Determination of ventral hernia presence during follow-up visits | Posted | Number | Hernia | Up to 1 year follow-up |
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| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Infection / Abscess / Sepsis | Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods | Posted | Number | Total events | Up to 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Bowel Obstruction | Determination of bowel obstruction during the entire available study follow-up period | Posted | Number | Bowel obstruction | Up to 1 year follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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
FOM Locomotion Subscale
FOM Expression/Communication Subscale
Glasgow Outcome Scale:
| Please see Outcome Measure Description [above] for exact measure(s) utilized, including measurement scale(s). | Posted | Mean | Standard Deviation | units on a scale | Up to 1 year follow-up |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Would Complication | Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint | Posted | Number | Wound complication | Up to 1 year follow-up period |
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Daily assessments for adverse events (AE) were performed during the initial hospitalization phase for each patient; Additional AE screening was done during outpatient visits; AE data were collected during up to 1 year voluntary follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seprafilm Group | Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation. | 2 | 17 | 5 | 17 | ||
| EG001 | No Seprafilm Group | Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group. | 1 | 13 | 5 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality | Surgical and medical procedures | Systematic Assessment | Two patients (2/17) in the Seprafilm group experienced 28-day mortality; One patient (1/13) in No Seprafilm group experienced 28-day mortality; Mortality was attributed to high injury severity and physiologic acuity; Not associated with the study. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 5/17 patients in Seprafilm group developed respiratory failure; 5/13 in No Seprafilm group developed respiratory failure; All instances of respiratory failure were related to injury severity / physiologic acuity; Not related to study conduct |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stanislaw P. Stawicki, M.D. | St. Luke's University Health Network | 484-526-4426 | stanislaw.stawicki@sluhn.org |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014951 | Wounds, Stab |
| ID | Term |
|---|---|
| D014950 | Wounds, Penetrating |
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| ID | Term |
|---|---|
| C118198 | Seprafilm |
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| Male |
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| Operation 3 |
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| Operation 4 |
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| Operation 5 |
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| Operation 6 |
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| Operation 7+ |
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