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Open Wound of Other and Unspecified Parts of AbdomenNCT02107781

Intra-abdominal Pressure Monitoring in Patients With Open Abdomen Undergoing Early Closure

An observational study of Open Wound of Other and Unspecified Parts of Abdomen, run by Michigan State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators will monitor the pressure generated inside the abdomen in a patient in whom the surgeon, for whatever reason, felt that the abdomen could not be closed at the initial operation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AbViser abdominal compartment pressure measuring device
Type of treatment
Medical device
How many people
17 participants
Where
1 siteUnited States
Study dates
Mar 2012to Jan 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Cohort of patients in ICU with open abdomen

Who may be able to join

  • Postoperative Surgical Patients who have not undergone abdominal closure, irrespective of the type of dressing used to protect the viscera

Who cannot join

  • Age less than 18 years
  • Coagulopathy
  • Moribund/not expected to survive 48 hrs
  • Patients in whom there is not a commitment to life supporting therapy
  • Patients who have had definitive closure at the time of operation
  • Patients in whom abdominal closure is not planned or not feasible

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sparrow Health System

    Lansing, Michigan, 48912

Other trials in United States

About this study

Official title: A Prospective Observational Study of Continuous Intra-abdominal Pressure Monitoring in Patients With Postoperative Open Abdomen Undergoing Early Intervention and Closure

The investigators will monitor the pressure generated inside the abdomen in a patient in whom the surgeon, for whatever reason, felt that the abdomen could not be closed at the initial operation. The investigators will aggressively treat rises in intra-abdominal pressure and see what changes, if any are found when the abdomen finally is closed.

Read the detailed description

The detrimental effects of elevated intra-abdominal compartment pressure have been known for some time and are actively managed by most surgical critical care physicians. Similarly, it is well known that occasionally the abdomen cannot be immediately closed in some patients due to concern of elevated intra-abdominal pressure or ongoing contamination; these patients typically stay in hospital, often in expensive ICU's until final closure - and even then, some patients do not get definitive reconstruction of the abdominal wall until many months later, again adding to the expense of their care. Thus, there has been a move to give these patients early, aggressive closure of the abdomen, often using a combination of negative pressure wound therapy and biologic mesh. Currently these groups of patients who have early aggressive closure are incompletely studied; although abdominal compartment pressure measurements are routinely made on them, this is not commonly done intra-operatively when closure is being performed; nor have these patients been studied with continuous monitoring. This is especially striking considering the occlusive nature of negative wound therapy dressings: anecdotal increases in abdominal pressures have been noted in these patients, sometimes to dangerous levels. As there is accumulating evidence that diligent management of intra-abdominal pressure can improve outcomes in a variety of patients, there is an opportunity to apply accurate monitoring to a patient group that is also likely to benefit.

The investigators propose a prospective observational study on patients who are unable to be definitively closed at the time of surgery and are candidates for early aggressive abdominal closure. The investigators will monitor abdominal pressure using the AbViser continuous abdominal pressure monitoring device to ascertain whether there are episodes if intra-abdominal hypertension in these patients, and whether this improves or not after definitive closure. The research team will then attempt to correlate abdominal pressure measurements to outcomes. Finally the team will compare patients to historical controls using propensity scoring to explore differences in outcome.

Intra-abdominal pressure monitoring will be initiated when a patient has been identified as requiring an open abdomen. The monitoring will be done until the patient's abdominal wound has been closed and there are no elevated measurements. Once the patient has been discharged from the intensive care unit, the AbViser system will be discontinued. Patients will continue to be followed for the duration of their hospital stay and outcome measures will be assessed until discharge from the hospital, an expected average of 2 - 3 weeks.

Being tested
AbViser abdominal compartment pressure measuring device
Keywords
Open abdomen, abdominal compartment pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbViser abdominal compartment pressure measuring deviceDevice

    Also called AbViser system, IAP system, Abdominal compartment syndrome monitor

    AbViser AutoValve IAP Monitoring Device will be used on all patient enrolled in the research study.

Study groups in NCT02107781
Study groupRoleWhat they receive
Patients with open abdomenPatients in a critical care unit with abdomen that was not closed during initial operation \& will have intra-abdominal pressure monitoring using the AbViser abdominal compartment pressure measuring device.
Receives: Device: AbViser abdominal compartment pressure measuring device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intra-abdominal pressure (IAP) Measurements

    The IAP will be recorded using the AbVisor system when abdomen is open, after surgical closure and will continue until the IAP system is discontinued

    Measured: From the time when the patient has surgery & the abdomen is left open, immediately after abdomen is closed & until the patient's IAP system is discontinued, an expected average of 1 - 3 weeks.

Secondary outcomes (1)
  1. Length of time in critical care unit

    The length of time subjects require monitoring in a critical care unit.

    Measured: From the time the patient is admitted to the critical care unit until discharged to a step-down unit. Measured immediately after discharge from critical care unit, an expected average of 1 - 3 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study startMar 2012
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107781
Sponsor's protocol ID
r041998
Status last verified
Jun 2020
First submitted
24 Jan 2014
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Open Wound of Other and Unspecified Parts of Abdomen, run by Michigan State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra-abdominal pressure (IAP) Measurements (time frame: From the time when the patient has surgery & the abdomen is left open, immediately after abdomen is closed & until the patient's IAP system is discontinued, an expected average of 1 - 3 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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