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Suction dressing vs repeat surgery: testing a gentler path through severe abdominal infection

NCT ID NCT03932461

NEW Disease control Sponsor: Odense University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 19, 2026 · Last updated Oct 19, 2026

Summary

This multicenter trial compares two ways to manage the abdomen after surgery for fecal or diffuse peritonitis, a severe infection of the abdominal lining. One approach uses a vacuum-assisted dressing that applies suction to the open abdomen. The other closes the abdomen and reoperates only if clinical signs call for it. Researchers will track peritonitis-related complications, mortality, and quality of life over one year in adults who have had emergency surgery for perforations of the small bowel, colon, or rectum.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vacuum-assisted abdominal closure, a dressing and pump system that applies suction to the open abdomen
What this could lead to
If it works, this approach could reduce repeat operations and complications for people with severe abdominal infections.
What could go wrong
The trial may show no clear advantage over standard care, and vacuum dressings carry risks such as bowel injury or infection. Results may not apply to all types of peritonitis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients eligible for enrolment are 18+ years of age and are scheduled for acute laparotomy due to suspected peritonitis originating from perforation of the small bowel, colon, or rectum. To be included, purulent, enteric, or fecal contamination in a minimum of 2 out of 4 quadrants must be confirmed. Exclusion Criteria: * Diffuse peritonitis originating from a different focus than the small intestine, colon or rectum * Diffuse peritonitis originating from a perforation on the stomach, duodenum, gallbladder, appendix, necrotizing pancreatitis, salpingitis, or peritoneal dialysis * Primary peritonitis * Immunocompromised (ongoing chemotherapy or prednisolone \>20 mg/day) * Chronic parenchymal liver disease * Pregnancy * Patients with end-stage disease * Laparoscopic surgery (not converted to laparotomy) * Acute occlusion of superior mesenteric artery * Peritoneal carcinomatosis * Abdominal trauma * Lack of consent from the surgical equipoise * Local peritonitis confined to 1 quadrant only

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Conditions

The condition(s) this trial relates to.

peritonitis septic peritonitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse; peritonitis Fecal peritonitis Secondary peritonitis

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Odense University Hospital

    RECRUITING

    Odense, Fyn, 5000, Denmark

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