Trial Outcomes & Findings for ABRA Abdominal Closure System in Open Abdomen Management (NCT NCT00754156)

NCT ID: NCT00754156

Last Updated: 2017-03-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

up to 12 months

Results posted on

2017-03-03

Participant Flow

Patients who met study criteria were enrolled from January 26, 2009 through December 6, 2010.

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.

Participant milestones

Participant milestones
Measure	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	2 V.A.C. or ABThera Alone ABThera V.A.C. Therapy alone
Overall Study STARTED	8	6
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ABRA Abdominal Closure System in Open Abdomen Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 ABRA Plus V.A.C or ABThera n=8 Participants ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy	V.A.C. or ABThera n=6 Participants V.A.C. or ABThera Therapy alone	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Continuous	49.9 years STANDARD_DEVIATION 12.4 • n=93 Participants	52.8 years STANDARD_DEVIATION 14.1 • n=4 Participants	51.14 years STANDARD_DEVIATION 3.4 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants
Region of Enrollment United States	8 participants n=93 Participants	6 participants n=4 Participants	14 participants n=27 Participants
BMI	25.7 Kg/m^2 STANDARD_DEVIATION 5.8 • n=93 Participants	38.0 Kg/m^2 STANDARD_DEVIATION 12.9 • n=4 Participants	30.99 Kg/m^2 STANDARD_DEVIATION 2.95 • n=27 Participants
Base Excess/Base Deficit	5.9 mmole/liter INTER_QUARTILE_RANGE 2.5-18.1 • n=93 Participants	5.1 mmole/liter INTER_QUARTILE_RANGE 0.5-9.8 • n=4 Participants	5.9 mmole/liter n=27 Participants
APACHE II	21.25 score STANDARD_DEVIATION 9.8 • n=93 Participants	16 score STANDARD_DEVIATION 11.6 • n=4 Participants	19.00 score STANDARD_DEVIATION 2.81 • n=27 Participants
Starting Wound Dimension	575.9 cm^2 STANDARD_DEVIATION 289.2 • n=93 Participants	359.2 cm^2 STANDARD_DEVIATION 245.3 • n=4 Participants	483 cm^2 STANDARD_DEVIATION 75.86 • n=27 Participants
Trauma	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants
Vascular/Splenectomy/AAA	3 participants n=93 Participants	0 participants n=4 Participants	3 participants n=27 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: Descriptive Study.

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

Outcome measures

Outcome measures
Measure	1 ABRA Plus ABThera n=8 Participants ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 ABThera n=6 Participants ABThera V.A.C. Therapy alone
Primary Closure Rate	75 % of participants	67 % of participants

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	1 ABRA Plus ABThera n=8 Participants ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 ABThera n=6 Participants ABThera V.A.C. Therapy alone
Number of Trips to the Operating Room	1 Number of trips Interval 1.0 to 1.0	3 Number of trips Interval 2.8 to 4.8

PRIMARY outcome

Timeframe: Duration of Hospital Stay less than 6 months

The amount of time needed to manage the open abdomen inside the operating room.

Outcome measures

Outcome measures
Measure	1 ABRA Plus ABThera n=8 Participants ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 ABThera n=6 Participants ABThera V.A.C. Therapy alone
Operating Room Time Utilization	58 Minutes Standard Deviation 29	212 Minutes Standard Deviation 115

SECONDARY outcome

Timeframe: Duration of Hospital Stay less than 6 months

Outcome measures

Outcome measures
Measure	1 ABRA Plus ABThera n=8 Participants ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 ABThera n=6 Participants ABThera V.A.C. Therapy alone
Days to Closure	9.5 Days Interval 4.5 to 18.0	7.5 Days Interval 5.56 to 10.3

SECONDARY outcome

Timeframe: Duration of hospital stay less than 6 months

Outcome measures

Outcome measures
Measure	1 ABRA Plus ABThera n=8 Participants ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 ABThera n=6 Participants ABThera V.A.C. Therapy alone
ICU Days	17 Days Interval 12.3 to 55.0	18 Days Interval 15.0 to 23.8

SECONDARY outcome

Timeframe: Duration of Hospital Stay less than 6 months

Outcome measures

Outcome measures
Measure	1 ABRA Plus ABThera n=8 Participants ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 ABThera n=6 Participants ABThera V.A.C. Therapy alone
Hospital Days	43.5 Days Interval 22.3 to 60.8	27.5 Days Interval 25.8 to 31.5

SECONDARY outcome

Timeframe: Duration of Hospital Stay less than 6 months

Outcome measures

Outcome measures
Measure	1 ABRA Plus ABThera n=8 Participants ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 ABThera n=6 Participants ABThera V.A.C. Therapy alone
Blood Transfused	2650 Units Interval 0.0 to 7493.0	0 Units Interval 0.0 to 758.0

Adverse Events

1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

2 V.A.C. or ABThera Alone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera n=8 participants at risk ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 V.A.C. or ABThera Alone n=6 participants at risk ABThera V.A.C. Therapy alone
Skin and subcutaneous tissue disorders Device failure and skin breakdown	12.5% 1/8 • Number of events 1 • Hospitalization of enrollment	0.00% 0/6 • Hospitalization of enrollment

Other adverse events

Other adverse events
Measure	1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera n=8 participants at risk ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy	2 V.A.C. or ABThera Alone n=6 participants at risk ABThera V.A.C. Therapy alone
Surgical and medical procedures Enterocutaneous Fistula	0.00% 0/8 • Hospitalization of enrollment	16.7% 1/6 • Number of events 1 • Hospitalization of enrollment

Additional Information

Phillip Chang, M.D. PI or Anna Rockich, Pharm.D. GSRP Director

University of Kentucky Medical Center

Phone: 859-323-6346

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER