Open Abdomen
Conditions
Keywords
Closure, Wounds
Brief summary
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.
Interventions
ABRA Abdominal Closure System
V.A.C. Therapy Alone
KCI ABThera
Sponsors
Study design
Eligibility
Inclusion criteria
1. ages of 18 and 70 2. patients deemed not a candidate for primary fascial closure at the second laparotomy.
Exclusion criteria
1. High risk for imminent death, as determined by the attending surgeon and PI 2. Pre-existing large ventral hernia 3. Significant loss of abdominal wall fascia as a result of trauma or infection 4. Known Crohn's disease 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Closure Rate | up to 12 months | The rate in which the abdomen was closed the first time. |
| Number of Trips to the Operating Room | 12 Months | — |
| Operating Room Time Utilization | Duration of Hospital Stay less than 6 months | The amount of time needed to manage the open abdomen inside the operating room. |
Secondary
| Measure | Time frame |
|---|---|
| Days to Closure | Duration of Hospital Stay less than 6 months |
| Blood Transfused | Duration of Hospital Stay less than 6 months |
| ICU Days | Duration of hospital stay less than 6 months |
| Hospital Days | Duration of Hospital Stay less than 6 months |
Countries
United States
Participant flow
Recruitment details
Patients who met study criteria were enrolled from January 26, 2009 through December 6, 2010.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 1 ABRA Plus V.A.C or ABThera ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy | 8 |
| V.A.C. or ABThera V.A.C. or ABThera Therapy alone | 6 |
| Total | 14 |
Baseline characteristics
| Characteristic | Total | V.A.C. or ABThera | 1 ABRA Plus V.A.C or ABThera |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 5 Participants | 7 Participants |
| Age, Continuous | 51.14 years STANDARD_DEVIATION 3.4 | 52.8 years STANDARD_DEVIATION 14.1 | 49.9 years STANDARD_DEVIATION 12.4 |
| APACHE II | 19.00 score STANDARD_DEVIATION 2.81 | 16 score STANDARD_DEVIATION 11.6 | 21.25 score STANDARD_DEVIATION 9.8 |
| Base Excess/Base Deficit | 5.9 mmole/liter | 5.1 mmole/liter | 5.9 mmole/liter |
| BMI | 30.99 Kg/m^2 STANDARD_DEVIATION 2.95 | 38.0 Kg/m^2 STANDARD_DEVIATION 12.9 | 25.7 Kg/m^2 STANDARD_DEVIATION 5.8 |
| Region of Enrollment United States | 14 participants | 6 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 7 Participants |
| Starting Wound Dimension | 483 cm^2 STANDARD_DEVIATION 75.86 | 359.2 cm^2 STANDARD_DEVIATION 245.3 | 575.9 cm^2 STANDARD_DEVIATION 289.2 |
| Trauma | 5 participants | 2 participants | 3 participants |
| Vascular/Splenectomy/AAA | 3 participants | 0 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 1 / 6 |
| serious Total, serious adverse events | 1 / 8 | 0 / 6 |
Outcome results
Number of Trips to the Operating Room
Time frame: 12 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 ABRA Plus ABThera | Number of Trips to the Operating Room | 1 Number of trips |
| 2 ABThera | Number of Trips to the Operating Room | 3 Number of trips |
Operating Room Time Utilization
The amount of time needed to manage the open abdomen inside the operating room.
Time frame: Duration of Hospital Stay less than 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 ABRA Plus ABThera | Operating Room Time Utilization | 58 Minutes | Standard Deviation 29 |
| 2 ABThera | Operating Room Time Utilization | 212 Minutes | Standard Deviation 115 |
Primary Closure Rate
The rate in which the abdomen was closed the first time.
Time frame: up to 12 months
Population: Descriptive Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 ABRA Plus ABThera | Primary Closure Rate | 75 % of participants |
| 2 ABThera | Primary Closure Rate | 67 % of participants |
Blood Transfused
Time frame: Duration of Hospital Stay less than 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 ABRA Plus ABThera | Blood Transfused | 2650 Units |
| 2 ABThera | Blood Transfused | 0 Units |
Days to Closure
Time frame: Duration of Hospital Stay less than 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 ABRA Plus ABThera | Days to Closure | 9.5 Days |
| 2 ABThera | Days to Closure | 7.5 Days |
Hospital Days
Time frame: Duration of Hospital Stay less than 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 ABRA Plus ABThera | Hospital Days | 43.5 Days |
| 2 ABThera | Hospital Days | 27.5 Days |
ICU Days
Time frame: Duration of hospital stay less than 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 ABRA Plus ABThera | ICU Days | 17 Days |
| 2 ABThera | ICU Days | 18 Days |