Negative Pressure Wound Therapy for Abdominal Infections

Overseen By Margo Mantz-Wichman, BS, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Under 18, Prisoners, Pregnant, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 7 days

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating abdominal wounds using negative pressure wound therapy, which employs vacuum pressure to aid healing. The researchers aim to determine if this method is safer and more effective than traditional approaches for individuals with contaminated or dirty wounds following surgery. Participants will receive treatment with a device called Abthera, which applies negative pressure therapy to support the healing process. The study seeks individuals who have undergone a specific type of abdominal surgery, midline laparotomy, and now have a contaminated or dirty wound.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future wound care treatments.

Do I need to stop my current medications for this trial?

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 this negative pressure wound therapy is safe for abdominal infections?

Research has shown that Negative Pressure Wound Therapy (NPWT) is a common and safe method for treating open wounds, including abdominal wounds, in both adults and children. Studies have found that NPWT helps prevent skin and tissue retraction after surgery or injury, improving healing. One clinical trial found NPWT effective and safe for healing subcutaneous abdominal wounds.

This treatment is generally well-tolerated, with no reports of major side effects. However, as with any treatment, monitoring for possible side effects is important, and discussing any concerns with a healthcare provider is advised. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Negative Pressure Wound Therapy (NPWT) for abdominal infections because it offers a unique approach to wound healing compared to traditional methods. Unlike standard treatments that often involve regular wound dressings and antiseptics, NPWT uses a vacuum-assisted device to apply controlled negative pressure to the wound, promoting faster healing and reducing infection risk. This method not only helps in managing complex abdominal wounds more effectively but also enhances blood flow and reduces edema, which are critical in speeding up recovery.

What evidence suggests that Negative Pressure Wound Therapy is effective for abdominal infections?

Research has shown that negative pressure wound therapy (NPWT), such as the Abthera system, can enhance healing for infected wounds after surgeries like laparotomies. In this trial, participants will receive standardized wound closure with negative pressure therapy. One study found that patients who received vacuum-assisted closure (VAC) therapy experienced significantly better wound healing. Another review found that NPWT successfully closed the abdominal lining in 72% of patients without severe infections. These treatments can help manage open abdominal wounds by promoting faster and more effective healing compared to traditional methods. However, uncertainty remains about their safety and effectiveness, and further research is needed to confirm these benefits. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who've had a midline laparotomy (a surgical cut down the middle of the abdomen) and have been managed with an open abdomen for at least one day due to contaminated or dirty wounds. Pregnant women, individuals under 18, prisoners, and non-surgical patients cannot participate.

Inclusion Criteria

I had surgery with an open abdomen technique for at least a day.

contaminated or dirty wound classification

Exclusion Criteria

Prisoners

I have not undergone surgery for my condition.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive negative pressure wound therapy (NPWT) for delayed primary closure of contaminated or dirty laparotomy wounds

7 days

Initial assessment between 2 and 5 days postoperatively

Follow-up

Participants are monitored for wound complications, infection, and readmission rates

30 days

Extension

Long-term monitoring of wound healing and cost of care

Additional 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Abthera

Trial Overview The study tests whether using negative pressure wound therapy (NPWT), specifically a device called Abthera, can improve healing in abdominal infections after surgery compared to leaving the abdomen open without NPWT. It aims to see if this method reduces complications like infections.

How Is the Trial Designed?

Group I: Historic Cohort Experimental Treatment 1 Intervention

Historic cohort have undergone a midline laparotomy and managed with an open abdomen for at least one day and have contaminated or dirty wound classification.

Group II: Negative Pressure Wound Therapy Active Control 1 Intervention

Standardized wound closure with negative pressure therapy.

Abthera is already approved in United States, European Union for the following indications:

Approved in United States as Abthera for:

• Surgical site infections
• Open abdominal wounds
• Traumatic wounds
• Diabetic foot ulcers
• Burn wounds

Approved in European Union as Abthera for:

• Surgical site infections
• Open abdominal wounds
• Traumatic wounds
• Diabetic foot ulcers
• Burn wounds

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Negative pressure wound therapy (NPWT) is effective for managing complicated abdominal wounds in infants, with a median treatment duration of 34 days and no significant NPWT-related complications reported.

In a study of 18 infants, NPWT was associated with a low incidence of new complications, as only 2 cases of new fistulas occurred, highlighting its safety in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of negative pressure wound therapy for abdominal wounds in neonates and infants. Stoffan, AP., Ricca, R., Lien, C., et al.[2019]

In a study involving 10 patients treated with vacuum-assisted closure (VAC) therapy, significant local clinical improvement was observed in all 3 cases of patients with intestinal fistulas, leading to better symptom control.

VAC therapy, despite its controversial use for intestinal fistulas, demonstrated potential benefits in improving wound conditions and patient comfort, although two patients ultimately passed away due to their complex medical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Negative pressure therapy in wounds with enteric fistulas]. Ruiz-López, M., Carrasco Campos, J., Sánchez Pérez, B., et al.[2009]

Routine combination antimicrobial therapy for gram-negative infections, such as those caused by Pseudomonas aeruginosa, is not supported by strong clinical evidence and may not improve patient outcomes compared to monotherapy.

While combination therapy can be justified in specific cases like patients with shock or neutropenia, it carries risks such as increased toxicity, costs, and potential for antibiotic resistance, making careful consideration essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is double coverage of gram-negative organisms necessary? Johnson, SJ., Ernst, EJ., Moores, KG.[2022]

In a retrospective study comparing two negative pressure therapy systems, the ABThera™ (ABT) system achieved a significantly higher primary closure rate of 41% compared to 11% for the V.A.C.® abdominal dressing (AD) system among open-abdomen patients.

Patients using the ABT system also required fewer days of therapy (17 days) compared to those using the AD system (26 days), and had a lower incidence of complications, with only 4% developing enteroatmospheric fistulae versus 17% in the AD group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of open abdomen treatment: ABThera™ vs. abdominal dressing™. Olona, C., Caro, A., Duque, E., et al.[2021]

In a retrospective study of patients treated with negative-pressure wound therapy (NPWT) from 2011 to 2014, having more than 7 changes of NPWT was identified as a significant predictor of mortality (P = .038).

While NPWT is effective for managing open abdominal wounds, prolonged use should be avoided, as it is associated with higher mortality rates, emphasizing the need for timely abdominal closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Negative-Pressure Wound Therapy for the Open Abdomen Benefit the Patient? A Retrospective Cohort Study. Krebs, B., Jagrič, T.[2018]

Ventilator-associated pneumonia (VAP) is a serious infection that occurs in patients on mechanical ventilation for over 48 hours, significantly affecting patient outcomes and healthcare costs.

Preventive strategies, often used as a bundle, have been effective in reducing the incidence of VAP, and timely collection of respiratory samples is crucial for appropriate empiric treatment based on local pathogen prevalence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilator-associated pneumonia. Bassi, GL., Ferrer, M., Marti, JD., et al.[2014]

Ventilator-associated pneumonia (VAP) is a serious infection that can occur after 48 hours of mechanical ventilation, but early removal from the ventilator and using non-invasive ventilation can help prevent it.

Starting appropriate antibiotic treatment quickly is crucial for improving outcomes in VAP, and preventative measures like subglottic suctioning and oral care are effective strategies to reduce the risk of this infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preventive strategies for nosocomial pneumonia]. Soma, K., Imai, H., Arai, M.[2011]

In a study involving three duroc swine, negative pressure wound therapy (NPWT) was found to have minimal impact on intraabdominal pressure, primarily affecting only superficial areas when sponge packing was used.

The application of NPWT did not cause any significant changes in vital signs or ventilatory pressures, suggesting it is safe for use in open abdomen management without hemodynamic concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-abdominal Pressure Monitoring During Negative Pressure Wound Therapy in the Open Abdomen. Travis, TE., Prindeze, NJ., Shupp, JW., et al.[2022]

In the phase III REPROVE trial involving 870 hospitalized adults with hospital-acquired or ventilator-associated pneumonia, ceftazidime-avibactam (CAZ-AVI) was found to be noninferior to meropenem in terms of 28-day all-cause mortality, indicating its effectiveness as a treatment option.

CAZ-AVI also demonstrated similar clinical cure rates compared to meropenem for patients infected with ceftazidime-nonsusceptible pathogens, suggesting it can effectively treat multidrug-resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Ceftazidime-Avibactam vs Meropenem for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (REPROVE): Analyses per US FDA-Specified End Points. Torres, A., Rank, D., Melnick, D., et al.[2022]

Negative pressure wound therapy (NPWT) effectively treated a giant hepatic abscess in a 28-year-old male after a gunshot wound, leading to significant reduction in abscess size and cessation of bile leakage over 15 days.

NPWT, especially with instillation therapy, can be beneficial even in the presence of infection, highlighting its potential as an adjunctive treatment for complex wounds like abscesses, although its use in such cases is still not fully established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy with intermittent irrigation for treatment of post-traumatic giant abscess: A case report. Abidali, M., Bauer, F., Gottlieb, M., et al.[2022]

In a complex case involving a 32-year-old man with colonic anastomotic leakage and severe septic shock, abdominal vacuum sealing (AVS) therapy effectively managed his open abdominal wound and facilitated recovery over a 2-month period.

AVS therapy proved to be a viable alternative to surgical repair for treating diffuse peritonitis in patients with poor medical conditions, highlighting its potential as a safe and effective intervention in challenging clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete abdominal wound and anastomotic leak with diffuse peritonitis closure achieved by an abdominal vacuum sealing drainage in a critical ill patient: a case report. Fujii, Y., Tajima, Y., Kaji, S., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9073087/

Negative pressure wound therapy for managing the open ... However, the safety and effectiveness of NPWT as a treatment for open abdomen is still uncertain. NPWT has been used in recent years to treat non‐trauma ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4990566/

Well-promising outcomes with vacuum-assisted closure in ... Compared to conventional methods, the use of VAC ends to better outcomes, in cases of infected wounds following laparotomy. Keywords: Vacuum-assisted closure, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1743919114008814

Systematic review and evidence based recommendations ... Results: Pooled results, in non-septic patients showed a 72% fascial closure rate following use of commercial NPWT kits in the open abdomen. This increased to ...

4. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2763979

Negative Pressure Wound Therapy vs Conventional ... This randomized clinical trial evaluate the effectiveness and safety of negative pressure wound therapy for subcutaneous abdominal wound ...

5. withpower.com withpower.com/trial/phase-intraabdominal-infections-7-2020-d1c9b

Negative Pressure Wound Therapy for Abdominal Infections In a study involving 10 patients treated with vacuum-assisted closure (VAC) therapy, significant local clinical improvement was observed in all 3 cases of ...

6. journals.lww.com journals.lww.com/jtrauma/fulltext/2025/08001/negative_pressure_wound_therapy_in.21.aspx

Negative pressure wound therapy in resource-limited... Negative pressure wound therapy also minimizes skin and soft tissue retraction that can occur after traumatic or surgical disruption of soft tissue, resulting ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22929494/

Negative-pressure wound therapy for critically ill adults ... We sought to determine the comparative efficacy and safety of NPWT versus alternate temporary abdominal closure (TAC) techniques in critically ill adults with ...