Experimental: ABRO™ Binder Arm for Intra-Abdominal Hypertension

Phase-Based Estimates
1
Effectiveness
1
Safety
St. Michael's Hospital, Toronto, Canada
Intra-Abdominal Hypertension+12 More
Experimental: ABRO™ Binder Arm - Device
Eligibility
Any Age
All Sexes
Eligible conditions
Intra-Abdominal Hypertension

Study Summary

This study is evaluating whether a new abdominal binder device called ABRO™ might help surgeons close the abdomen after an operation.

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Eligible Conditions

  • Intra-Abdominal Hypertension
  • Compartment Syndromes
  • Abdominal Injuries
  • Intraabdominal Infections
  • Abdominal Abscess
  • Peritonitis
  • Aortic Aneurysm, Abdominal
  • Abdominal Trauma
  • Abdominal Sepsis
  • Infection Abdominal
  • Abdominal Aortic Aneurysms (AAA)
  • Abdominal Compartment Syndrome
  • Abdominal Injury

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Experimental: ABRO™ Binder Arm will improve 1 primary outcome in patients with Intra-Abdominal Hypertension. Measurement will happen over the course of Outcome measures will record when closure of the abdomen takes place up to 11 days after randomization..

Day 11
Total number of patients who experience complete abdominal closure with sutures without the use of mesh and/or component separation.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Usual Care
Device: ABRO™Binder Arm
Placebo group

This trial requires 140 total participants across 2 different treatment groups

This trial involves 2 different treatments. Experimental: ABRO™ Binder Arm is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Device: ABRO™Binder Arm
Device
Intervention is the usual care (listed above) plus a novel new abdominal binder device called ABRO™
Usual Care
Device
The current approach for temporary coverage of abdomen is called "vacuum assisted techniques (VAT)". This technique requires the use of vacuum-assisted drainage to remove blood or watery fluid from a wound or operative site.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: outcome measures will record when closure of the abdomen takes place up to 11 days after randomization.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly outcome measures will record when closure of the abdomen takes place up to 11 days after randomization. for reporting.

Closest Location

St. Michael's Hospital - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex of any age. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Mechanically ventilated patients, managed with the OA strategy.
16 years of age or older

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get intra-abdominal hypertension a year in the United States?

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About 5 million Americans have IAH each year. IAH is associated with increased mortality, especially in those with cirrhosis. At least 5% of US patients requiring liver transplantation have IAH.

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What are the signs of intra-abdominal hypertension?

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Signs include extreme abdominal pain, palpable abdominal distension and tenderness, an abnormal increase of white cell count and an increase in arterial CO2 level in the abdominal aorta.

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What is intra-abdominal hypertension?

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In many patients presenting with abdominal tenderness with clinical signs of acute illness such as confusion, nausea, vomiting, and abdominal pain, intra-abdominal pressure is increased to a greater degree than a normal reading, because of an abnormally compliant retroperitoneum. Patients who have increased intra-abdominal pressure (>20 cm H2O) should undergo prompt surgical exploration to rule out abdominal pathologic conditions such as a perforated/tender and free fluid. However, for an appropriately selected patient, in the setting of low intra-abdominal pressure (<20 cm H2O), one may delay, and even withhold, explorative laparoscopy until definitive diagnostic tests such as a CT have been obtained.

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Can intra-abdominal hypertension be cured?

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The inability to exclude a spontaneous cause of intra-abdominal hypertension suggests that IAH of intra-abdominal pressure < 6 mmHg is not necessarily associated with an intra-abdominal disorder. In a few patients intra-abdominal pressure > 6 mmHg may in fact be related to intra-abdominal disorders. Thus further research is required to determine whether IAP > 6 mmHg is related to the pathology of intra-abdominal disorders.

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What are common treatments for intra-abdominal hypertension?

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Sepsis remains the major cause of death in the intensive care unit (ICU). In ICDS patients, sepsis is the most common cause of death. Although various studies showed that most often hypotensive shock is caused either by sepsis or by cardiac arrest, current recommendations recommend a diagnostic and therapeutic approach similar regardless between the first or second type of ICDS. However, there is no specific treatment for hypotensive shock.

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What causes intra-abdominal hypertension?

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Intra-abdominal hypertension may be caused by a variety of disorders. The diagnosis can be delayed by insufficient knowledge of the disease or of the physical examination. In these cases of IAH, an urgent abdominal CT is advisable.

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Is experimental: abro™ binder arm safe for people?

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The effectiveness of the IAP-BA and its ease of use, in conjunction with other treatments (e.g. fluids, blood), support its use for the management of IAH in severely ill patients who would otherwise be unable to tolerate invasive treatment.

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Has experimental: abro™ binder arm proven to be more effective than a placebo?

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In this series, 1.5 months of Abrobinder treatment produced no difference in IAP, IAP change and IAP variability compared to placebo. IAP decreased following IAP reduction which could be explained by a spontaneous decrease.

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What are the latest developments in experimental: abro™ binder arm for therapeutic use?

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Arterial grafts can be used to maintain patency and prevent thrombosis of grafts in the treatment of abdominal aortic aneurysms, in accordance with the most modern studies, that reported excellent survival. In the experimental field, we showed that the binder arterial graft, produced with the Arterial Binder-Abro (ABA) device, can reduce intraluminal distension after arterial grafts from grafts perforated during aortic operation and be an effective and safe experimental approach to treat abdominal aortic aneurysms, through the incorporation of tissue engineering techniques.

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Who should consider clinical trials for intra-abdominal hypertension?

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The prevalence of clinically important IAH at presentation and in the acute period is increasing and increasing health care expenditure are at risk of being the cause. A group of patients with IAH should be targeted for referral to clinical trials in a multicentre manner. Patients with IAH associated with intra-abdominal hypertension should be targeted for a clinical trial.

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What is the latest research for intra-abdominal hypertension?

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Findings from a recent study showed that there is not enough information available about the risk factors involved in IAH, what makes this condition difficult to diagnose, what is the most effective and non-traumatic method to treat IAH, and how the consequences of IAH cause the damage to the organs.

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