Instillation vs Traditional Negative Pressure Wound Therapy: A Pilot Randomized Controlled Trial for Necrotizing Soft Tissue Infections (NPWTi-NSTI Trial)
HealthPartners Institute
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention * Age \>/=18 years old * Planned application of a negative pressure wound dressing Exclusion Criteria: * 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 * Patients \<18 years old
Interventions
- DeviceNegative Pressure Wound Therapy
NPWT creates a vacuum seal over your wound to promote healing
- DeviceNegative Pressure Wound Therapy with Instillation
NPWTi creates a vacuum seal over your wound and infuses the wound with hypochlorous acid (medical grade dilute bleach) to clean it.
Location
- Regions HospitalSaint Paul, Minnesota