Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections (NPWT-NSTI)

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

Study Overview

• Status: Recruiting
• Conditions: Necrotizing Soft Tissue Infections
• Intervention / Treatment: Device: Negative Pressure Wound Therapy; Device: Negative Pressure Wound Therapy with Instillation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas J Larson; Phone Number: 651-254-4846; Email: RegionsSurgicalResearch@HealthPartners.com

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Recruiting
      • Regions Hospital
      • Contact: Nicholas J Larson; Phone Number: 651-254-4846; Email: RegionsSurgicalResearch@HealthPartners.com
      • Principal Investigator: Brian S Myer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Negative Pressure Wound Therapy; Patients in this arm will receive traditional Negative Pressure Wound Therapy (NPWT)	Device: Negative Pressure Wound Therapy; NPWT creates a vacuum seal over your wound to promote healing; Other Names: 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)	Device: Negative 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.; Other Names: NPWTi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned hospital readmission	Did the patient have an unplanned readmission to the hospital (Y/N) within 30 days of discharge	Within 30 days of discharge
Rate of healing	Time from index debridement to final coverage in days	First operation and last operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of operative interventions	Number of times the patient required an operation related to their NSTI during their hospital stay	Through hospital discharge, median of 9 days
Unplanned vac change	Number of unplanned times the vacuum dressing had to be changed during their hospital stay	Through hospital discharge, median of 9 days
Total vac changes	Total number of times the vacuum dressing was changed (planned + unplanned) during their hospital stay	Through hospital discharge, median of 9 days
Bleeding	Bleeding at wound vac site (Y/N). During hospital stay	Through hospital discharge, median of 9 days
Infection	New infection at wound vac site (Y/N). During hospital stay	Through hospital discharge, median of 9 days
Hospital length of stay	Number of days spent in Hospital	At hospital discharge, median of 9 days
Intensive Care Unit length of stay	Number of days spent in the Intensive Care Unit	At hospital discharge, median of 9 days
Floor length of stay	Number of days spent inpatient in the hospital	At hospital discharge, median of 9 days
Skilled Nursing Facility days	Number of days spent in a skilled nursing facility	Up to 6 months after admission to skilled nursing facility
Discharge disposition	"Where was the patient discharged: ""1=Discharged/Transferred to a short-term general hospital for inpatient care 2=Discharged/Transferred to an Intermediate Care Facility (ICF) 3=Discharged/Transferred to home under care of organized home health service 4=Left against medical advice or discontinued care 5=Deceased/Expired 6=Discharged to home or self-care (routine discharge) 7=Discharged/Transferred to Skilled Nursing Facility (SNF) 8=Discharged/Transferred to hospice care 9=Discharged/Transferred to court/law enforcement. 10=Discharged/Transferred to inpatient rehab or designated unit 11=Discharged/Transferred to Long Term Care Hospital (LTCH) 12=Discharged/Transferred to a psychiatric hospital or psychiatric distinct part unit of a hospital 13=Discharged/Transferred to another type of institution not defined elsewhere"""	At hospital discharge, median of 9 days

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: University of Minnesota
• Investigators: Principal Investigator: Brian S Myer, MD, Regions Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: August 11, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Negative pressure wound therapy; NPWT; NPWTi
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Soft Tissue Infections; Therapeutics; Surgical Procedures, Operative; Drainage; Wound Closure Techniques; Negative-Pressure Wound Therapy
• Other Study ID Numbers: A24-205; 0002758892 (Other Grant/Funding Number: University of Minnesota Translational Center for Resuscitative Trauma Care)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes