Closed vs. Open Abdomen Management for Sepsis

Overseen By Andrew Kirkpatrick, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Pregnant, Severe IAH, Pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24-72 hours

550 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective randomized clinical study. The study will comprise the randomized decision to either A) primarily close the fascia after laparotomy for intra-abdominal infection (CLOSED); or B) leave the fascia open after laparotomy and apply a temporary abdominal closure (TAC) device (OPEN) with a vacuum drain. Although debatable, both procedures (CLOSED or OPEN abdomen) are acceptable based on current suggested standard of care. Thus, high quality data to direct clinical decision making in this highly lethal condition is urgently required.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Closed Abdomen Management for Sepsis?

Research suggests that using vacuum-assisted closure (VAC) for managing an open abdomen in septic patients can lead to faster abdominal closure and fewer complications compared to other methods. This implies that similar techniques in closed abdomen management might also be effective in improving outcomes for sepsis patients. ^{1 2 3 4 5}

Is temporary abdominal closure generally safe for humans?

Temporary abdominal closure (TAC) is commonly used in cases of trauma and infection, and while it is generally safe, it can lead to complications such as the need for further abdominal wall reconstruction in some patients. ^{1 3 5 6 7}

How does the treatment for sepsis using closed vs. open abdomen management differ from other treatments?

This treatment is unique because it compares two approaches: keeping the abdomen closed after surgery or leaving it open with a temporary closure using a special dressing. The open abdomen method allows for better management of infection and swelling, but it is controversial due to potential complications, while the closed method aims for quicker recovery by closing the abdomen sooner. ^{1 4 5 8 9}

Research Team

Andrew W Kirkpatrick, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adults with severe abdominal sepsis, indicated by specific scores like the World-Society-of-Emergency-Surgery-Sepsis-Severity Score >8. It's not for pregnant individuals, those with high intra-abdominal pressure (IAP>20 mmHg), patients without plans for continued care, cases of pancreatitis-induced peritonitis, or uncontrolled bleeding.

Inclusion Criteria

I am currently experiencing septic shock.

World-Society-of-Emergency-Surgery-Sepsis-Severity-Score > 8

Predisposition-Infection-Response-Organ Dysfunction Score > 3

Exclusion Criteria

My peritonitis is caused by pancreatitis.

I do not have any ongoing issues with uncontrolled bleeding.

I do not plan to continue receiving treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo either closed or open abdomen management with ANPPT dressing after laparotomy for severe intra-abdominal infection

24-72 hours

Intra-operative randomization and initial post-operative care

Follow-up

Participants are monitored for survival, blood IL-6 levels, and ICU stay duration

90 days

Regular follow-up visits and monitoring

Post-operative Care

Formal abdominal closure or dressing change at 24-72 hours from placement

1-3 days

Treatment Details

Interventions

• Closed Abdomen Management
• Open Abdomen Management with ANPPT dressing

Trial Overview The study compares two methods to manage abdominal infections after surgery: 'Closed Abdomen Management' where the surgical cut is closed right away and 'Open Abdomen Management' where it's left open with a vacuum dressing applied. Participants are randomly assigned to one of these treatments.

Participant Groups

Group I: Open Abdomen Management with ANPPT dressing Active Control 1 Intervention

The abdominal fascia will not be closed, but a temporally abdomenal closure (TAC) dressing (such as AbThera dressing) will be placed to protect the viscera with active Negative Pressure Peritoneal drain. Formal abdominal closure or dressing change at 24-72 hours from placement should be performed.

Group II: Closed Abdomen Management Placebo Group 1 Intervention

Primary closure of the abdominal fascia with placement of an intra-peritoneal drain (such as a Jackson-Pratt drain). Any decision to perform a re-laparotomy will be at the discretion of the treating surgical team.

Closed Abdomen Management is already approved in European Union, United States for the following indications:

Approved in European Union as Primary Fascial Closure for:

• Abdominal sepsis
• Intra-abdominal infection

Approved in United States as Primary Fascial Closure for:

• Abdominal sepsis
• Intra-abdominal infection

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Findings from Research

The artificial burr technique and vacuum-assisted closure (VAC) method are associated with the highest rates of delayed primary fascial closure (90% and 60%, respectively) in patients with an open abdomen due to trauma or infection.

Both the artificial burr and VAC techniques also demonstrate lower mortality rates (17% and 18%, respectively), indicating they are not only effective but also safer options for temporary abdominal closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary closure of the open abdomen: a systematic review on delayed primary fascial closure in patients with an open abdomen. Boele van Hensbroek, P., Wind, J., Dijkgraaf, MG., et al.[2022]

In a study comparing 27 patients using vacuum-assisted closure (VAC) to 31 patients using other temporary abdominal closure methods, VAC significantly reduced the duration of open abdomen treatment and the number of dressing changes, indicating its efficiency in managing septic abdomens.

VAC also showed superior outcomes in terms of re-exploration rates, successful abdominal closure rates, and a lower incidence of enteroatmospheric fistulas, making it a safer and more effective option for temporary abdominal closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of vacuum-assisted closure in septic patients treated with laparostomy. Pliakos, I., Papavramidis, TS., Michalopoulos, N., et al.[2012]

The implementation of a standardized protocol for patients undergoing emergent laparotomy and temporary abdominal closure led to a significant increase in primary fascial closure rates from 81% to 93% without increasing complication rates, based on a study of 138 patients.

Patients following the protocol received lower volumes of intravenous fluids and had shorter intervals between surgeries, indicating improved management strategies that may enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of standardized protocol implementation for surgical damage control and temporary abdominal closure after emergent laparotomy. Loftus, TJ., Efron, PA., Bala, TM., et al.[2020]

In a study of 211 patients with severe abdominal sepsis, the use of vacuum-assisted closure (VAC) for open abdomen management resulted in a significantly lower mortality rate (22.8%) compared to primary abdominal closure (PAC) (38.6%).

Controlling for disease severity, the odds of mortality were 59% lower for patients treated with VAC compared to those treated with PAC, indicating that VAC may be a more effective strategy for improving survival in these critical cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open abdomen with negative pressure device vs primary abdominal closure for the management of surgical abdominal sepsis: a retrospective review. Bleszynski, MS., Chan, T., Buczkowski, AK.[2017]

A study comparing 77 trauma patients and 147 septic patients undergoing temporary abdominal closure (TAC) revealed that trauma patients had higher rates of hypothermia, severe acidosis, and coagulopathy, while septic patients required more vasopressor support, indicating different resuscitation needs for each group.

Among patients who survived to discharge, trauma patients had a higher primary fascial closure (PFC) rate of 90% compared to 76% for septic patients, suggesting that the underlying conditions significantly affect surgical outcomes and closure success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary abdominal closure for trauma and intra-abdominal sepsis: Different patients, different outcomes. Loftus, TJ., Jordan, JR., Croft, CA., et al.[2018]

In a review of 19 patients managed for open abdomen over five years, the overall definitive fascial closure (DFC) rate was 70.6%, indicating a reasonable success rate for this procedure in a district hospital setting.

Despite the acceptable DFC rate, the study noted a significant complication rate among survivors, with 13 out of 17 experiencing at least one major complication, highlighting the resource-intensive nature of managing open abdomens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the open abdomen in a district general hospital. De Siqueira, J., Tawfiq, O., Garner, J.[2021]

In a study of 150 military patients who underwent laparotomy, 94% of those who had temporary abdominal closure (TAC) were able to achieve delayed primary fascial closure, indicating a high success rate for this approach.

The incidence of incisional hernias was similar between patients who had TAC and those who had primary fascial closure, with 12% and 13% respectively, suggesting that TAC does not significantly increase the risk of hernia formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of open abdominal management following military trauma. Pengelly, S., Berry, JEA., Herrick, SE., et al.[2021]

There is currently no strong evidence that leaving the abdomen open (open abdomen) is more effective than closing it (closed abdomen) for treating abdominal sepsis and trauma, which are the main reasons for this approach.

While various temporary closure techniques exist for open abdomen management, they are linked to high rates of complications, and negative pressure wound therapy is commonly used, although no specific technique has been proven superior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management and treatment options for patients with open abdomen. Gurusamy, K., Davidson, B.[2017]

In a study of 355 adult patients treated with the open abdomen technique, those who achieved fascial closure had a higher initial rate of open abdomen procedures and shorter times to subsequent operations, indicating that early intervention may improve closure outcomes.

The presence of pancreatitis was identified as a negative prognostic factor for achieving fascial closure, while factors like the timing of operations and initial treatment method positively influenced closure success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fascial closure after open abdomen: initial indication and early revisions are decisive factors--a retrospective cohort study. Lambertz, A., Mihatsch, C., Röth, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Temporary closure of the open abdomen: a systematic review on delayed primary fascial closure in patients with an open abdomen. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The value of vacuum-assisted closure in septic patients treated with laparostomy. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of standardized protocol implementation for surgical damage control and temporary abdominal closure after emergent laparotomy. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Open abdomen with negative pressure device vs primary abdominal closure for the management of surgical abdominal sepsis: a retrospective review. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Temporary abdominal closure for trauma and intra-abdominal sepsis: Different patients, different outcomes. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Managing the open abdomen in a district general hospital. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Outcome of open abdominal management following military trauma. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Management and treatment options for patients with open abdomen. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Fascial closure after open abdomen: initial indication and early revisions are decisive factors--a retrospective cohort study. [2022]