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Infection AbdominalNCT04042259

Delayed Primary Closure Using Negative Pressure Wound Therapy

A study testing Abthera and Open adbdomen for post-laparotomy without NPWT device in people with Infection Abdominal, run by Medical College of Wisconsin at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Surgical site infection rates for contaminated or dirty laparotomy wounds can be as high as 45%. Surgical management of dirty and contaminated wounds has been controversial in the literature and between surgeons. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infection Abdominal
What is being tested?
Abthera and Open adbdomen for post-laparotomy without NPWT device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
3 Aug 2020to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 18 years or older
  • undergone midline laparotomy and managed with an open abdomen for at least one day
  • contaminated or dirty wound classification

Who cannot join

  • Less than 18 years of age
  • Prisoners
  • Pregnant females
  • Non-surgical patients

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Surgical site infection rates for contaminated or dirty laparotomy wounds can be as high as 45%. Surgical management of dirty and contaminated wounds has been controversial in the literature and between surgeons. Primary closure (PC) of these wounds can lead to multiple complications including surgical site infection (SSI), necrotizing soft tissue infection, wound and fascial dehiscence, evisceration, sepsis and hernia development. However, an alternative technique of utilizing secondary intention results in prolonged healing time and increased cost and healthcare resource utilization. Delayed primary closure (DPC) was developed to address many of these issues. Bhangu completed a systematic review and meta-analysis comparing primary versus delayed primary skin closure in contaminated and dirty abdominal wounds. They included 8 studies randomizing 623 patients with contaminated or dirty abdominal wounds to either DPC or PC. The most common diagnosis was appendicitis (77.4%), followed by perforated abdominal viscus (11.5%), ileostomy closure (6.5%), trauma (2.7%), and intra-abdominal abscess/other peritonitis (1.9%). The time to first assessment for DPC was between 2 and 5 days postoperatively. In all studies, the DPC group had significantly less SSIs using a fixed-effect model (odds ratio, 0.65; 95%CI, 0.40-0.93; P = .02). However, heterogeneity was high (72%), and using a random-effects model, the effect was no longer significant (odds ratio, 0.65; 95% CI, 0.25-1.64; P = .36). Additionally, all of the studies were found to be at high risk of bias, with marked deficiencies in study design and outcome assessment.

A recent systematic review showed improved fascial closure rates with negative pressure wound therapy (NPWT) Yet, a large national study using NPWT to perform a DPC has been shown to actually decrease the rate of closure. Access to NPWT has increased over the years and innovative wound management techniques including incisional application of negative pressure therapy have allowed clinicians to apply this method to dirty wounds following the principles of delayed primary closure. There are currently no studies available to help determine the safety and efficacy of advanced NPWT techniques to optimize surgical wound management from the open abdomen to skin closure. Within our Division, we have decided to make a practice change and develop a standard closure plan for open abdomens using the negative pressure devices available within our institution.

Being tested
Abthera, Open adbdomen for post-laparotomy without NPWT device
Medical subject headings
Intraabdominal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbtheraDevice

    Also called VERAFLO, Prevena

    Negative Pressure Wound Therapy Device

  • Open adbdomen for post-laparotomy without NPWT deviceProcedure or surgery

    Historic cohort treatment of open abdomen for dirty wounds without use of negative pressure therapy device

Study groups in NCT04042259
Study groupRoleWhat they receive
Negative Pressure Wound TherapyActive comparatorStandardized wound closure with negative pressure therapy.
Receives: Device: Abthera
Historic CohortOtherHistoric cohort have undergone a midline laparotomy and managed with an open abdomen for at least one day and have contaminated or dirty wound classification.
Receives: Procedure: Open adbdomen for post-laparotomy without NPWT device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30 day wound complication rate

    Wound infection, dehiscence, evisceration

    Measured: 30 days

  2. 30 day readmission

    Patient discharged and readmitted to primary care

    Measured: 30 days

  3. Days of Abthera, VERAFLO, and Prevena use

    Use of negative pressure wound therapy

    Measured: through wound closure, an average of 30 days

  4. Closure of Fascia

    Measure of days to closure of fascia

    Measured: 7 days

  5. Closure of Skin

    Measure of days to closure of skin

    Measured: 7 days

  6. Cost of care

    Total cost for wound care

    Measured: days to wound closure an average of 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2019
  2. Study start3 Aug 2020
  3. Primary completion6 Sep 2025
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04042259
Sponsor's protocol ID
PRO00032783
Status last verified
Jul 2026
First submitted
29 Jul 2019
Last updated
10 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Abthera and Open adbdomen for post-laparotomy without NPWT device in people with Infection Abdominal, run by Medical College of Wisconsin 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

30 day wound complication rate (time frame: 30 days). The study lists 6 primary outcomes in all. 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 10 Jul 2026.

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