Open Abdomen, Abdominal Adhesions, Trauma, Wounds and Injury
Conditions
Keywords
Open Abdomen, Damage Control, Trauma, Wound healing, Gun shot wounds, Stab wounds, Automobile accidents, Wounds and Injury
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.
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.
Interventions
BIOLOGICALSeprafilm
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.
Sponsors
Stan Stawicki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesion Characteristics | 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
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Characteristics | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Mortality | 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 | Up to 1 year post-injury | Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval |
| Infection / Abscess / Sepsis | Up to 1 year | Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods |
| Patient Functional Outcomes | 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 |
| Would Complication | Up to 1 year follow-up period | Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint |
| Ventral Hernia | Up to 1 year follow-up | Determination of ventral hernia presence during follow-up visits |
| Bowel Obstruction | Up to 1 year follow-up | Determination of bowel obstruction during the entire available study follow-up period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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:
* 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. | 17 |
| No Seprafilm Patients in this group will not receive Seprafilm during re-operations. Otherwise, their surgical management will be identical to the Seprafilm Group. | 13 |
| Total | 30 |
Baseline characteristics
| Characteristic | Seprafilm | No Seprafilm | Total |
|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 16.7 | 40.2 years STANDARD_DEVIATION 16.3 | 40.3 years STANDARD_DEVIATION 16.3 |
| Region of Enrollment United States | 17 participants | 13 participants | 30 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 17 | 5 / 13 |
| serious Total, serious adverse events | 2 / 17 | 1 / 13 |
Outcome results
Primary
Adhesion Characteristics
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
Time frame: Up to 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seprafilm | Adhesion Characteristics | Operation 2 | 1.13 Scores on a scale | Standard Error 0.34 |
| Seprafilm | Adhesion Characteristics | Operation 5 | 1.21 Scores on a scale | Standard Error 0.39 |
| Seprafilm | Adhesion Characteristics | Operation 3 | 1.54 Scores on a scale | Standard Error 0.69 |
| Seprafilm | Adhesion Characteristics | Operation 6 | 1.50 Scores on a scale | Standard Error 0.77 |
| Seprafilm | Adhesion Characteristics | Operation 1 | 1.06 Scores on a scale | Standard Error 0.24 |
| Seprafilm | Adhesion Characteristics | Operation 7+ | 1.38 Scores on a scale | Standard Error 0.25 |
| Seprafilm | Adhesion Characteristics | Operation 4 | 1.39 Scores on a scale | Standard Error 0.49 |
| No Seprafilm | Adhesion Characteristics | Operation 7+ | 2.84 Scores on a scale | Standard Error 0.23 |
| No Seprafilm | Adhesion Characteristics | Operation 2 | 1.08 Scores on a scale | Standard Error 0.28 |
| No Seprafilm | Adhesion Characteristics | Operation 3 | 1.19 Scores on a scale | Standard Error 0.32 |
| No Seprafilm | Adhesion Characteristics | Operation 4 | 1.63 Scores on a scale | Standard Error 0.58 |
| No Seprafilm | Adhesion Characteristics | Operation 5 | 2.33 Scores on a scale | Standard Error 0.82 |
| No Seprafilm | Adhesion Characteristics | Operation 6 | 2.92 Scores on a scale | Standard Error 0.83 |
| No Seprafilm | Adhesion Characteristics | Operation 1 | 1.08 Scores on a scale | Standard Error 0.28 |
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.
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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 04 | 223 Square Centimeters (cm2) | Standard Deviation 278 |
| Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 12 | 35 Square Centimeters (cm2) | Standard Deviation 5 |
| Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 02 | 282 Square Centimeters (cm2) | Standard Deviation 224 |
| Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 24 | 66 Square Centimeters (cm2) | Standard Deviation 30 |
| Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 08 | 76 Square Centimeters (cm2) | Standard Deviation 70 |
| Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 32 | 64 Square Centimeters (cm2) | Standard Deviation 55 |
| Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Time 0 | 419 Square Centimeters (cm2) | Standard Deviation 238 |
| No Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 32 | 59 Square Centimeters (cm2) | Standard Deviation 36 |
| No Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Time 0 | 393 Square Centimeters (cm2) | Standard Deviation 225 |
| No Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 02 | 322 Square Centimeters (cm2) | Standard Deviation 231 |
| No Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 04 | 218 Square Centimeters (cm2) | Standard Deviation 199 |
| No Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 08 | 210 Square Centimeters (cm2) | Standard Deviation 176 |
| No Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 12 | 116 Square Centimeters (cm2) | Standard Deviation 28 |
| No Seprafilm | Wound Healing Characteristics | Composite wound size (cm2): Week 24 | 148 Square Centimeters (cm2) | Standard Deviation 106 |
Other Pre-specified
Bowel Obstruction
Determination of bowel obstruction during the entire available study follow-up period
Time frame: Up to 1 year follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seprafilm | Bowel Obstruction | 0 Bowel obstruction |
| No Seprafilm | Bowel Obstruction | 1 Bowel obstruction |
Other Pre-specified
Enterocutaneous and Other Fistula
Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval
Time frame: Up to 1 year post-injury
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seprafilm | Enterocutaneous and Other Fistula | 3 Total events |
| No Seprafilm | Enterocutaneous and Other Fistula | 6 Total events |
Other Pre-specified
Infection / Abscess / Sepsis
Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods
Time frame: Up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seprafilm | Infection / Abscess / Sepsis | 4 Total events |
| No Seprafilm | Infection / Abscess / Sepsis | 3 Total events |
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 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
Time frame: Up to 1 year follow-up
Population: Please see Outcome Measure Description \[above\] for exact measure(s) utilized, including measurement scale(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seprafilm | Patient Functional Outcomes | Self-Feeding Score | 2.93 units on a scale | Standard Deviation 1.44 |
| Seprafilm | Patient Functional Outcomes | Locomotion Score | 2.6 units on a scale | Standard Deviation 1.24 |
| Seprafilm | Patient Functional Outcomes | Expression / Communication | 3.47 units on a scale | Standard Deviation 1.13 |
| Seprafilm | Patient Functional Outcomes | Glasgow Outcome Score | 4.07 units on a scale | Standard Deviation 0.8 |
| No Seprafilm | Patient Functional Outcomes | Glasgow Outcome Score | 3.40 units on a scale | Standard Deviation 0.97 |
| No Seprafilm | Patient Functional Outcomes | Self-Feeding Score | 3.25 units on a scale | Standard Deviation 1.14 |
| No Seprafilm | Patient Functional Outcomes | Expression / Communication | 3.45 units on a scale | Standard Deviation 1.21 |
| No Seprafilm | Patient Functional Outcomes | Locomotion Score | 2.25 units on a scale | Standard Deviation 0.87 |
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)
Time frame: 28 days & end of follow-up
Population: Note: Both mortalities in the Seprafilm group involved withdrawal of care as per previously stated patient wishes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seprafilm | Patient Mortality | 2 Mortalities |
| No Seprafilm | Patient Mortality | 1 Mortalities |
Other Pre-specified
Ventral Hernia
Determination of ventral hernia presence during follow-up visits
Time frame: Up to 1 year follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seprafilm | Ventral Hernia | 1 Hernia |
| No Seprafilm | Ventral Hernia | 0 Hernia |
Other Pre-specified
Would Complication
Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint
Time frame: Up to 1 year follow-up period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seprafilm | Would Complication | 5 Wound complication |
| No Seprafilm | Would Complication | 3 Wound complication |