Study of Primary Fascial Closure Rate in Patients With Open Abdomen Treated With Abthera Versus Barker Technique

Abdominal Compartment Syndrome Clinical Trial

Official title:

Study of Primary Fascial Closure Rate in Patients With Open Abdomen Treated With Abthera Versus Barker Technique

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02952976
• Other study ID #: number1-oct-2016
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 28, 2016
• Last updated: April 24, 2017
• Start date: July 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: April 2017
• Source: Sociedade Brasileira de Atendimento Integrado ao Trauma
• Contact: Diogo Garcia, MD PhD FACS
• Phone: +5511996131077
• Email: diogogarcia[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to compare two different Temporary Abdominal Closure methods that could be used in cases like yours. The methods being compared are the Barker's vacuum packing technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera).

Description:

This study is being done to compare two different Temporary Abdominal Closure methods that could be used in cases of open abdomen. The methods being compared are the Barker's vacuum packing technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera). The BVPT will be made up by an internal plastic layer to cover abdominal viscera, a second layer with surgical sponges and a suction drain and will be covered by an adhesive plastic layer. Then the dressing will be connected to the hospital's vacuum system. The ABThera dressing is available commercially.

Study Participants Enrollment will happen at the operating room

Investigator will include in this study patients who have the following indications to laparostomy:

• Damage control surgery in trauma patients,

• Patients with abdominal compartment syndrome,

• Septic shock patients requiring short surgery and inability to close the abdominal cavity.

Signing the consent form will be held in order of preference by:

1. Patient

2. Legal representative

3. Doctor appointed by the hospital that does not participate in the study(only in cases where the urgency of the surgery do not allow contact with the representatives).

In the latter case the signature of the term should be applied to the legal representative as soon as possible.

Criteria for inclusion and exclusion:

Inclusion:

• Patients with indication of an open abdomen According to the Attending physician (above criteria)

Exclusion:

• Pregnancy;

• Chronic renal impairment,

• Child-Pugh C,

• Body index over 40 kg / m2,

• Uncontrolled bleeding during laparotomy

• Patients progressing to death within the first 48 hours

Allocation Concealment and Randomization Randomization will be performed by central online dedicated site in the ratio of 1: 1.

When a patient is eligible, a surgeon will access the Web site, enter patient's information to know the assigned allocation.

Variable block size randomization will be utilized stratified by study center

Assuming a closure rate of 75% in the Abthera arm and 35% in the Control arm, a study with 36 patients in each treatment arm (72 total) would have 90% power to detect such a difference at the 0.05 significance level.

In order to evaluate closure for 36 patients in each arm, with an estimated loss of 30% either by withdraw or death prior to 48h. So the study will enroll 94 patients (47 in each treatment group) After surgery, patients will be referred to the intensive care unit (ICU). In patients' Barker Group a fenestrated plastic will be used and that will be in contact with viscera followed by four pads with a suction drain and an adhesive finishing layer.

In ABThera group technique the dressing will be done according to the description and the manufacturer's instructions (Acelity, San Antonio, TX).

Primary Objective :

• Fascial closure in 30 days

Secondary objectives

• Demographic variables (gender, age, comorbidities, mechanism of injury or disease),

• Indication of laparostomy,

• Systolic blood pressure,

• Amount of fluid drained by the healing of laparostomy,

• Amount of crystalloid,

• Amount of hemoconcentrated,

• APACHE II ICU admission,

• Length of stay in the ICU,

• Length of mechanical ventilation,

• Length of hospital stay,

• Time to closure

• Adverse Events

• Complications

• Mortality.

In trauma patients the score Revised Trauma (RTS) and the Injury Severity Score (ISS) will be calculated

Statistical analysis

Descriptive variables will be summarized as frequencies and percentages. Continuous variable data will be presented as means and standard deviations or medians and ranges, depending on the distribution.

The analysis of the qualitative variables will be done through measures of association (chi-square or Fisher 's exact test). The analysis of quantitative variables will be made by means of different tests (parametric and nonparametric) depending on the outcome of the applied normality test

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with indication of an open abdomen According to the Attending physician

• Damage control surgery in trauma patients,

• Patients with abdominal compartment syndrome,

• Septic shock patients requiring short surgery and inability to close the abdominal cavity.

Exclusion Criteria:

• Pregnancy;

• Chronic renal impairment,

• Child-Pugh C,

• Body index over 40 kg / m2,

• Uncontrolled bleeding during laparotomy

• Patients progressing to death within the first 48 hours

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Abdominal Injuries
• Abdominal Sepsis
• Abdominal Trauma
• Compartment Syndromes
• Intra-Abdominal Hypertension

Intervention

Device:
• Abthera
ABThera group technique the dressing will be done according to the description and the manufacturer's instructions (Acelity, San Antonio, TX).
• Barker
In Barker Group a fenestrated plastic will be used and that will be in contact with viscera followed by four pads with a suction drain and an adhesive finishing layer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sociedade Brasileira de Atendimento Integrado ao Trauma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day fascial closure	Percentage of facial closure in each arm	30 day
Secondary	Mortality	Percentage of mortality closure in each arm	30 days
Secondary	Drainage	Amount of fluid in ml drained by the dressing	30 days