Negative Pressure Wound Therapy for Flesh-eating Bacteria
(NPWT-NSTI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods for treating wounds from necrotizing soft tissue infections, which are serious and fast-spreading. The trial compares traditional negative pressure wound therapy, which uses suction to remove fluid, with an advanced version called Negative Pressure Wound Therapy with Instillation. This advanced method also cleans the wound with a special solution. Researchers aim to determine if the advanced method leads to quicker healing and fewer hospital visits. Individuals with a confirmed serious skin infection requiring surgery might be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to innovative treatments that could enhance future care for serious 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 wound therapy devices are safe for treating necrotizing soft tissue infections?
Research has shown that Negative Pressure Wound Therapy with Instillation (NPWTi) is generally well-tolerated by patients. Studies have found that NPWTi can accelerate wound healing and reduce harmful bacteria in the wound. No major reports of serious side effects, such as the need for additional surgery or hospital readmission, have emerged, indicating that the treatment is usually safe.
Traditional Negative Pressure Wound Therapy (NPWT) is also a well-accepted method for treating wounds and has been used successfully for various types, including surgical and accidental wounds. Both NPWT and NPWTi are considered safe, with NPWTi potentially speeding up healing without introducing new risks.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for flesh-eating bacteria because they offer innovative methods compared to standard care like antibiotics and surgical debridement. Negative Pressure Wound Therapy (NPWT) uses suction to remove fluids and bacteria from wounds, which can speed up healing. In this trial, there's also an experimental version called NPWT with Instillation (NPWTi), which adds a hypochlorous acid solution that might better target bacteria and cleanse the wound more effectively. These approaches could potentially enhance healing and reduce the need for more invasive procedures.
What evidence suggests that this trial's treatments could be effective for necrotizing soft tissue infections?
Research shows that Negative Pressure Wound Therapy (NPWT), one of the treatments in this trial, helps wounds heal by lowering the air pressure on them. This technique has proven effective in aiding healing for patients with necrotizing fasciitis, a serious flesh-eating infection. In this trial, some participants will receive NPWT, while others will receive Negative Pressure Wound Therapy with Instillation (NPWTi), which combines NPWT with a cleaning solution. Studies indicate that NPWTi can lead to better results. Specifically, one study found that NPWTi led to complete wound healing in 50% of patients, compared to 23.3% with just NPWT. Additionally, NPWTi can speed up healing and shorten hospital stays. These findings suggest NPWTi may be more effective for treating complex wounds from infections like necrotizing fasciitis.23678
Who Is on the Research Team?
Brian S Myer, MD
Principal Investigator
Regions Hospital
Are You a Good Fit for This Trial?
This trial is for patients with Necrotizing Soft Tissue Infections, commonly known as flesh-eating bacteria. It's aimed at those who require wound management after surgical removal of infected tissue. Specific eligibility criteria are not provided, but typically participants would need to be stable enough for the treatment and without conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either traditional Negative Pressure Wound Therapy (NPWT) or NPWT with instillation (NPWTi) during their hospital stay
Follow-up
Participants are monitored for safety and effectiveness after treatment, including unplanned hospital readmissions
Extended Follow-up
Participants may be monitored for additional outcomes such as time spent in a skilled nursing facility
What Are the Treatments Tested in This Trial?
Interventions
- Negative Pressure Wound Therapy
- Negative Pressure Wound Therapy with Instillation
Find a Clinic Near You
Who Is Running the Clinical Trial?
HealthPartners Institute
Lead Sponsor
University of Minnesota
Collaborator