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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of managing the abdomen after surgery for severe abdominal infections. One method involves immediate closure of the abdomen (CLOSED, or Closed Abdomen Management), while the other keeps it open temporarily with a special dressing and vacuum drain (OPEN, or Open Abdomen Management with ANPPT dressing). The study aims to determine which approach is more effective for treating this serious condition. Individuals who have experienced a major abdominal infection with leakage into the abdomen during surgery and are in septic shock may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to important research that could enhance treatment options for severe abdominal infections.

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 prior data suggests that these management techniques are safe for sepsis treatment?

Research shows that using an open abdomen management approach with a temporary abdominal closure (TAC) and negative pressure wound therapy (ANPPT) is generally safe, though risks exist. One study found that about 76.6% of patients successfully had their abdomen closed using this method. However, complications included a 7.2% chance of developing a fistula, an abnormal connection between organs, and 29.7% of patients experienced infection-related issues.

Other studies have shown that a vacuum-assisted closure system can achieve a high rate of successful abdominal closure, around 90%. However, patients with severe abdominal infections (abdominal sepsis) may face worse outcomes than those treated for injuries, with a higher chance of complications.

These findings suggest that while open abdomen management with ANPPT dressing is often effective, it carries some risk, especially in cases of severe infection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different surgical techniques for managing sepsis, which is a life-threatening condition. The trial is evaluating whether keeping the abdomen closed with a drain or using an open abdomen approach with an ANPPT dressing is better. The open abdomen method uses a special dressing that applies negative pressure, which might help control infection and improve healing. This trial could provide valuable insights into which approach leads to better outcomes for patients with sepsis, potentially changing how this condition is managed in the future.

What evidence suggests that this trial's treatments could be effective for sepsis?

This trial will compare Closed Abdomen Management with Open Abdomen Management using an ANPPT dressing. Research has shown that a temporary abdominal closure (TAC) device, such as an ANPPT dressing, effectively treats severe abdominal infections. Studies have found that this method can increase the likelihood of successfully closing the abdominal wall later. It may also reduce death rates and shorten hospital stays for patients with severe abdominal infections. However, patients with abdominal infections might experience worse outcomes compared to those with injuries when using this method. Despite these challenges, incorporating negative pressure wound therapy (NPWT) into the TAC has effectively managed serious abdominal infections. ^{1 4 6 7 8}

Who Is on the Research Team?

Andrew W Kirkpatrick, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9686976/

Retrospective Study of Indications and Outcomes of Open ... Abdominal closure with negative pressure wound therapy (NPWT) has shown rates of DFC around 90%. We conducted a retrospective study to evaluate ...

2. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-abdominal-wall-surgery/articles/10.3389/jaws.2025.14119/full

Narrative Review of Open Abdomen Management and ... The consequences of not closing an abdomen in a timely manner can lead to frozen or hostile abdomens as well as other complications such as ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2210261216305028

Management of the open abdomen using negative ... NPWT-I in patients with severe abdominal sepsis had promising results, since we obtained higher fascia closure rates, lower mortality and reduced hospital and ...

4. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-015-0032-7

The role of the open abdomen procedure in managing severe ... Compared with trauma patients, patients with abdominal sepsis have been described to have worse outcomes after OA, with increased incidence of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12185356/

Narrative Review of Open Abdomen Management and ... The ideal temporary abdominal closure technique (TAC) should be easy to use, require limited dressing changes, prevent abdominal fascia ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3706408/

Open abdomen management: A review of its history and ... They achieved fascial closure rates of 76.6% in intention-to-treat analysis and 89% in per-protocol analysis. They had a 7.2% fistula rate and a 29.7% in- ...

7. mdpi.com mdpi.com/2079-6382/11/11/1498

Retrospective Study of Indications and Outcomes of Open ... Abdominal closure with negative pressure wound therapy (NPWT) has shown rates of DFC around 90%. We conducted a retrospective study to evaluate ...

8. east.org east.org/education-resources/practice-management-guidelines/details/open-abdomen-management-a-review-part-2

Open Abdomen Management, A Review: Part 2 Treatment of the open abdomen with the commercially available vacuum-assisted closure system in patients with abdominal sepsis: low primary closure rate.