Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections

NCT07120386 | Recruiting FDA Device

• 2 other identifiers: A24-2050002758892
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Necrotizing Soft Tissue Infections

Keywords

Negative pressure wound therapy; NPWT; NPWTi

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Number of operative interventions

  Through hospital discharge, median of 9 days

• Unplanned vac change

  Through hospital discharge, median of 9 days

• Total vac changes

  Through hospital discharge, median of 9 days

Study Arms (2)

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

Patients in this arm will receive traditional Negative Pressure Wound Therapy (NPWT)

Device: Negative Pressure Wound Therapy

Negative Pressure Wound Therapy with Instillation

EXPERIMENTAL

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

Interventions

Negative Pressure Wound Therapy DEVICE

NPWT creates a vacuum seal over your wound to promote healing

Also known as: NPWT

Negative Pressure Wound Therapy

Negative Pressure Wound Therapy with Instillation DEVICE

NPWTi creates a vacuum seal over your wound and infuses the wound with hypochlorous acid (medical grade dilute bleach) to clean it.

Also known as: NPWTi

Negative Pressure Wound Therapy with Instillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention
• Age \>/=18 years old
• Planned application of a negative pressure wound dressing

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• University of Minnesota: collaborator

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Brian S Myer, MD

  Regions Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas J Larson

CONTACT

651-254-4846; RegionsSurgicalResearch@HealthPartners.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 13, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)