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ABRA Abdominal Closure System in Open Abdomen Management

A Prospective, Controlled Evaluation of ABRA Abdominal Wall Closure System in Combination With V.A.C. Therapy Compared to V.A.C. Alone in the Management of Open Abdomen

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00754156
Acronym
ABRA
Enrollment
14
Registered
2008-09-17
Start date
2008-09-30
Completion date
2011-12-31
Last updated
2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Abdomen

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

DEVICEABRA Abdominal Closure System

ABRA Abdominal Closure System

V.A.C. Therapy Alone

KCI ABThera

Sponsors

Anna Rockich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Primary Closure Rateup to 12 monthsThe rate in which the abdomen was closed the first time.
Number of Trips to the Operating Room12 Months
Operating Room Time UtilizationDuration of Hospital Stay less than 6 monthsThe amount of time needed to manage the open abdomen inside the operating room.

Secondary

MeasureTime frame
Days to ClosureDuration of Hospital Stay less than 6 months
Blood TransfusedDuration of Hospital Stay less than 6 months
ICU DaysDuration of hospital stay less than 6 months
Hospital DaysDuration 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

ArmCount
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
Total14

Baseline characteristics

CharacteristicTotalV.A.C. or ABThera1 ABRA Plus V.A.C or ABThera
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
12 Participants5 Participants7 Participants
Age, Continuous51.14 years
STANDARD_DEVIATION 3.4
52.8 years
STANDARD_DEVIATION 14.1
49.9 years
STANDARD_DEVIATION 12.4
APACHE II19.00 score
STANDARD_DEVIATION 2.81
16 score
STANDARD_DEVIATION 11.6
21.25 score
STANDARD_DEVIATION 9.8
Base Excess/Base Deficit5.9 mmole/liter5.1 mmole/liter5.9 mmole/liter
BMI30.99 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 participants6 participants8 participants
Sex: Female, Male
Female
4 Participants3 Participants1 Participants
Sex: Female, Male
Male
10 Participants3 Participants7 Participants
Starting Wound Dimension483 cm^2
STANDARD_DEVIATION 75.86
359.2 cm^2
STANDARD_DEVIATION 245.3
575.9 cm^2
STANDARD_DEVIATION 289.2
Trauma5 participants2 participants3 participants
Vascular/Splenectomy/AAA3 participants0 participants3 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 81 / 6
serious
Total, serious adverse events
1 / 80 / 6

Outcome results

Primary

Number of Trips to the Operating Room

Time frame: 12 Months

ArmMeasureValue (MEDIAN)
1 ABRA Plus ABTheraNumber of Trips to the Operating Room1 Number of trips
2 ABTheraNumber of Trips to the Operating Room3 Number of trips
Primary

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

ArmMeasureValue (MEAN)Dispersion
1 ABRA Plus ABTheraOperating Room Time Utilization58 MinutesStandard Deviation 29
2 ABTheraOperating Room Time Utilization212 MinutesStandard Deviation 115
p-value: <0.01Wilcoxon (Mann-Whitney)
Primary

Primary Closure Rate

The rate in which the abdomen was closed the first time.

Time frame: up to 12 months

Population: Descriptive Study.

ArmMeasureValue (NUMBER)
1 ABRA Plus ABTheraPrimary Closure Rate75 % of participants
2 ABTheraPrimary Closure Rate67 % of participants
Secondary

Blood Transfused

Time frame: Duration of Hospital Stay less than 6 months

ArmMeasureValue (MEDIAN)
1 ABRA Plus ABTheraBlood Transfused2650 Units
2 ABTheraBlood Transfused0 Units
Secondary

Days to Closure

Time frame: Duration of Hospital Stay less than 6 months

ArmMeasureValue (MEDIAN)
1 ABRA Plus ABTheraDays to Closure9.5 Days
2 ABTheraDays to Closure7.5 Days
Secondary

Hospital Days

Time frame: Duration of Hospital Stay less than 6 months

ArmMeasureValue (MEDIAN)
1 ABRA Plus ABTheraHospital Days43.5 Days
2 ABTheraHospital Days27.5 Days
Secondary

ICU Days

Time frame: Duration of hospital stay less than 6 months

ArmMeasureValue (MEDIAN)
1 ABRA Plus ABTheraICU Days17 Days
2 ABTheraICU Days18 Days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026