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For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal compartment syndrome, and critically ill surgical patients with profound acidosis. While these advances have saved lives, they have also led to a dramatic increase in patients with open abdominal cavities. Various methods have been employed to offer protection to the viscera and at the same time, encourage gradual closure of the abdominal fascia. Some of the techniques have included the Bogota bag, vacuum pack described by Barker , Wittman patch , and the use of vacuum assisted fascia-closure, including the commercially available system offered by KCI. Overall, the abdominal closure rate is approximately 50% to 90% over an average of 10 days. Unfortunately, there has been no well-designed comparison study available. Some of the best results also require returning to the operating room every 3 to 5 days.
At the University of Kentucky Medical Center, a combination of the vacuum pack dressing described by Barker, the commercially available VAC system (V.A.C.; KCI International, San Antonio, TX) and vicryl mesh closure systems are used. The primary fascial closure rate is approximately 50%. It is not standard practice to take patients to the OR every 3-5 days routinely.
Recently, a new FDA listed system (ABRA by Canica) has been introduced using a progressive tension system as a novel approach to the management of open abdomen. ABRA provides a dynamic reduction of full thickness, severely retracted midline abdominal defects with the goal of maintaining or restoring the primary closure option. This subdermal method uses button anchors and elastomer to gradually pull the wound margins together. Tension can be set and adjusted according to the desired outcome; to stabilize a retracted wound, reduce the wound, close the wound or prevent wound dehiscence (Attachment 1: Company brochure). Currently there is only one published case report of the success of this device. We hope to be the first center to prospectively report a series of patients with open abdomen managed with the new ABRA system. In this study, this system will be used in combination with a standard therapy used in abdominal wound closure at the University of Kentucky Medical Center. This system is called the V.A.C system (V.A.C.; KCI International, San Antonio, Tx). This therapy provides active exudate management and containment, assists in reducing abdominal volume and adds structural stabilization to adipose tissue.
Although no highly powered study has been done to establish data on performance, individual experiences at several institutions have reached fascial closure rates of higher than 70% using the ABRA device. One institution in Las Vegas, Nevada is using the ABRA device in combination with the VAC system and has experienced 100% closure rate to date with 12 patients. The purpose of this study is to collect information about the ABRA system in combination with the VAC technique at the University of Kentucky Medical Center. It is our belief that using this system will improve the fascial closure rate and thereby produce less chance of hernia and reduce long periods of open abdominal wounds. The objective of the study is to evaluate a novel approach for closure of open abdomen utilizing the Canica ABRA system combined with the K.C.I. VAC System to KCI VAC System alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 ABRA plus KCI ABThera or KCI VAC | Active Comparator | ABRA Abdominal Wound Closure System in combination with KCI ABThera or KCI VAC |
|
| KCI V.A.C. Therapy or ABThera Alone | Active Comparator | KCI V.A.C. Therapy ABThera Alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABRA Abdominal Closure System | Device | ABRA Abdominal Closure System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Closure Rate | The rate in which the abdomen was closed the first time. | up to 12 months |
| Number of Trips to the Operating Room | 12 Months | |
| Operating Room Time Utilization | The amount of time needed to manage the open abdomen inside the operating room. | Duration of Hospital Stay less than 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Closure | Duration of Hospital Stay less than 6 months | |
| ICU Days | Duration of hospital stay less than 6 months | |
| Hospital Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Chang, M.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
Study candidates were identified following index laparotomy where the abdominal cavity could not be closed primarily. Following informed consent, patients were enrolled if attempts at primary closure were unsuccessful during the second laparotomy.
Patients who met study criteria were enrolled from January 26, 2009 through December 6, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera | ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy |
| FG001 | 2 V.A.C. or ABThera Alone | ABThera V.A.C. Therapy alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 ABRA Plus V.A.C or ABThera | ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy |
| BG001 | V.A.C. or ABThera | V.A.C. or ABThera Therapy alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Primary Closure Rate | The rate in which the abdomen was closed the first time. | Descriptive Study. | Posted | Number | % of participants | up to 12 months |
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Hospitalization of enrollment
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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 | 1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera | ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device failure and skin breakdown | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mass amount of drainage and infection and absence of wound edge for > 3 days required ABRA removal. Following removal 2 JP drains and wound vac was required. Soft tissue debridement was needed where the ABR button pads rested. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enterocutaneous Fistula | Surgical and medical procedures | Systematic Assessment | This patient developed an entercutaneous fistula during her involvement with the study. She recovered without issue |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Chang, M.D. PI or Anna Rockich, Pharm.D. GSRP Director | University of Kentucky Medical Center | 859-323-6346 | 247 | arockich@uky.edu |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| V.A.C. Therapy | Device | V.A.C. Therapy Alone |
|
| KCI ABThera | Device | KCI ABThera |
|
| Duration of Hospital Stay less than 6 months |
| Blood Transfused | Duration of Hospital Stay less than 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Body Mass Index | Mean | Standard Deviation | Kg/m^2 |
|
| Base Excess/Base Deficit | In human physiology, base excess and base deficit refer to an excess or deficit, respectively, in the amount of base present in the blood. The value is usually reported as a concentration in units mmol/L, with a positive number indicating excess of base and a negative deficit. A range for base excess or base deficit is -3 to + 3 mmol/L | Median | Inter-Quartile Range | mmole/liter |
|
| APACHE II | APACHE II (Acute Physiology and Chronic Health Evaluation) scoring system is an objective assessment of severity of illness in patients in the ICU. Scores can range from 0 (low severity) to 71 (high severity). | Mean | Standard Deviation | score |
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| Starting Wound Dimension | Mean | Standard Deviation | cm^2 |
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| Trauma | Number of patients that are trauma patients | Number | participants |
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| Vascular/Splenectomy/AAA | Patients who met criteria for entry who had baseline conditions to include vascular issue or splenectomy | Number | participants |
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| Participants |
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| Primary | Number of Trips to the Operating Room | Posted | Median | Inter-Quartile Range | Number of trips | 12 Months |
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| Primary | Operating Room Time Utilization | The amount of time needed to manage the open abdomen inside the operating room. | Posted | Mean | Standard Deviation | Minutes | Duration of Hospital Stay less than 6 months |
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| Secondary | Days to Closure | Posted | Median | Inter-Quartile Range | Days | Duration of Hospital Stay less than 6 months |
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| Secondary | ICU Days | Posted | Median | Inter-Quartile Range | Days | Duration of hospital stay less than 6 months |
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| Secondary | Hospital Days | Posted | Median | Inter-Quartile Range | Days | Duration of Hospital Stay less than 6 months |
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| Secondary | Blood Transfused | Posted | Median | Inter-Quartile Range | Units | Duration of Hospital Stay less than 6 months |
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| 1 |
| 8 |
| 0 |
| 8 |
| EG001 | 2 V.A.C. or ABThera Alone | ABThera V.A.C. Therapy alone | 0 | 6 | 1 | 6 |
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