About this trial
Necrotizing Soft Tissue Infections (NSTIs) are rapidly progressing infections that have a high morbidity and mortality, with the greatest morbidity related to managing the large wounds required to treat these patients. Initial treatment requires wide surgical removal of infected tissue and optimal management is essential to reducing morbidity in these patients. Negative pressure wound therapy (NPWT) is a widely used technology that has revolutionized wound management. NPWT is utilized across the spectrum of acute wounds, including routine postoperative incision management, traumatic wounds, and wounds related to surgical debridement of NSTIs which are frequently some of the most complicated of wounds encountered. Most NSTI cases at Regions Hospital currently utilize negative pressure wound therapy with instillation (NPWTi) where the wound is irrigated to clean out debris. Currently, there is a paucity of data comparing traditional NPWT and NPWTi and the choice of which device to use is left to surgeon discretion. This study is a first step at identifying the effects of NPWTi compared to NPWT alone on the care of NSTI patients. If the theoretical benefits of NPWTi over NPWT translate to practice, those treated with NPWTi would be expected to have a reduced rate of hospital readmission after their index hospitalization in addition to shorter time to definitive closure/coverage. This is a pilot study to assess the feasibility of enrolling patients with NSTIs in a randomized controlled trial to assess outcomes between the two devices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention
Age >/=18 years old
Planned application of a negative pressure wound dressing
Disqualifiers
Patients who have a wound that does not allow for a wound vac
Patients receiving acute treatment for a NSTI at another institution
Incarcerated patients
Patients who do not survive to wound closure/coverage
Trial design
Parallel
Treatments tested in this trial
Negative Pressure Wound Therapy
DeviceNPWT creates a vacuum seal over your wound to promote healing
Negative Pressure Wound Therapy with Instillation
DeviceNPWTi creates a vacuum seal over your wound and infuses the wound with hypochlorous acid (medical grade dilute bleach) to clean it.
Treatment groups
Trial outcomes
Primary outcomes
Unplanned hospital readmission
Did the patient have an unplanned readmission to the hospital (Y/N) within 30 days of discharge
Rate of healing
Time from index debridement to final coverage in days
Other outcomes
Number of operative interventions
Number of times the patient required an operation related to their NSTI during their hospital stay
Unplanned vac change
Number of unplanned times the vacuum dressing had to be changed during their hospital stay
Total vac changes
Total number of times the vacuum dressing was changed (planned + unplanned) during their hospital stay
Bleeding
Bleeding at wound vac site (Y/N). During hospital stay
Sponsors and contacts
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HealthPartners Institute
Lead sponsor
University of Minnesota
Collaborator