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CompletedNCT02107781Updated Jun 11, 2020

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

An observational study in Open Wound of Other and Unspecified Parts of Abdomen, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Michigan State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Open Wound of Other and Unspecified Parts of Abdomen

Keywords

  • Open abdomen
  • abdominal compartment pressure
03

In context

Lead sponsor

Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cohort of patients in ICU with open abdomen

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with open abdomen

    Patients 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.

    Device: AbViser abdominal compartment pressure measuring device

Interventions

  • DeviceAbViser abdominal compartment pressure measuring device

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

    Also known as: AbViser system, IAP system, Abdominal compartment syndrome monitor

06

What researchers measure

Primary outcomes

  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

    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.

Secondary outcomes

  1. Length of time in critical care unit

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

    Time frame: 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.

07

Study locations

1 site
  • Sparrow Health System
    Lansing, Michigan 48912, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02107781
Lead sponsor
Michigan State University
Collaborators
ConvaTec Inc.
Responsible party
Benjamin Mosher (Assistant Professor, Department of Surgery, Michigan State University) — Principal investigator
First posted
Apr 8, 2014
Start date
Mar 2012
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Jun 11, 2020

Study contacts

Benjamin D. Mosher, MD
principal investigator · Michigan State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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