Instillation vs Traditional Negative Pressure Wound Therapy: A Pilot Randomized Controlled Trial for Necrotizing Soft Tissue Infections (NPWTi-NSTI Trial)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention

• Age \>/=18 years old

• Planned application of a negative pressure wound dressing

Locations
United States
Minnesota
Regions Hospital
RECRUITING
Saint Paul
Contact Information
Primary
Nicholas J Larson
RegionsSurgicalResearch@HealthPartners.com
651-254-4846
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 30
Treatments
Active_comparator: Negative Pressure Wound Therapy
Patients in this arm will receive traditional Negative Pressure Wound Therapy (NPWT)
Experimental: Negative Pressure Wound Therapy with Instillation
Patients in this arm will receive Negative Pressure Wound Therapy with Instillation of a hypochlorous acid solution (NPWTi)
Related Therapeutic Areas
Sponsors
Leads: HealthPartners Institute
Collaborators: University of Minnesota

This content was sourced from clinicaltrials.gov