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

Trial Summary

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 data supports the effectiveness of the treatment Abthera, Negative Pressure Wound Therapy (NPWT), or Vacuum Assisted Closure (VAC) for abdominal infections?

The research mentions that Negative Pressure Wound Therapy (VAC) has been used to treat complex wounds, including those with intestinal fistulas, which are similar to abdominal infections. This suggests that VAC may be effective in managing difficult wound conditions. ^{1 2 3 4 5}

Is Negative Pressure Wound Therapy (NPWT) safe for humans?

Negative Pressure Wound Therapy (NPWT) is widely used and recognized as a safe method for managing open wounds, including abdominal wounds, in both adults and infants. It helps stabilize the wound environment and increase blood flow, although specific safety data for different conditions may vary. ^{6 7 8 9 10}

How is the treatment Abthera different from other treatments for abdominal infections?

Abthera, a type of negative pressure wound therapy (NPWT), is unique because it uses a vacuum to apply controlled pressure to the wound, which helps stabilize the wound environment, increase blood flow, and promote tissue growth. This method is particularly effective for managing complex abdominal wounds and infections, offering a modern approach compared to traditional wound care methods. ^{7 8 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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 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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Negative pressure therapy in wounds with enteric fistulas]. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Is double coverage of gram-negative organisms necessary? [2022]

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

Ventilator-associated pneumonia. [2014]

4. Japan pubmed.ncbi.nlm.nih.gov

[Preventive strategies for nosocomial pneumonia]. [2011]

5. United States 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. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Comparative study of open abdomen treatment: ABThera™ vs. abdominal dressing™. [2021]

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

Use of negative pressure wound therapy for abdominal wounds in neonates and infants. [2019]

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

Intra-abdominal Pressure Monitoring During Negative Pressure Wound Therapy in the Open Abdomen. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy with intermittent irrigation for treatment of post-traumatic giant abscess: A case report. [2022]

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

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

11. England 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. [2018]