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.
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
- Conditions the study is for
- Open Wound of Other and Unspecified Parts of Abdomen
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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.
- First posted8 Apr 2014 (estimated)
- Study startMar 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Wound of Other and Unspecified Parts of AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTec Inc.
- Responsible party
- Principal investigator, Benjamin Mosher, Michigan State University
- Investigators
- Benjamin D. Mosher, MD, Principal investigator, Michigan State University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Continuous Intra-abdominal Pressure Monitoring in Patients With Postoperative Open Abdomen Undergoing Early Intervention and Closure
- ClinicalTrials.gov ID
- NCT02107781
- Acronym / sponsor ID
- r041998
- Keywords
- Open abdomen, abdominal compartment pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- ConvaTec Inc.
- Study start
- Mar 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with open abdomen | – | Device: AbViser abdominal compartment pressure measuring devicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients in ICU with open abdomen
Key inclusion criteria (1 listed)
- Postoperative Surgical Patients who have not undergone abdominal closure, irrespective of the type of dressing used to protect the viscera
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbViser abdominal compartment pressure measuring deviceAlso: AbViser system, IAP system, Abdominal compartment syndrome monitorAbViser AutoValve IAP Monitoring Device will be used on all patient enrolled in the research study. | Device | Patients with open abdomen |
Primary outcome
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.
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
1 secondary outcome
Length of time in 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin D. Mosher, MD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
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.