Recruiting

NPWT vs. NPWTi

Sponsor:

HealthPartners Institute

Code:

NCT07120386

Conditions

Necrotizing Soft Tissue Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Negative Pressure Wound Therapy

Negative Pressure Wound Therapy with Instillation

Study Details

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

Study ID

NCT07120386

Start date

Aug 1, 2025

Status verified date

Sep, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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)

Interventions

Negative Pressure Wound Therapy

NPWT creates a vacuum seal over your wound to promote healing

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.

Primary outcome measure

  • Unplanned hospital readmission [ Time Frame: Within 30 days of discharge ]
  • Rate of healing [ Time Frame: First operation and last operation ]

Central Contacts and Locations

Locations

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

Brian S Myer, MD

More Information

Sponsor

HealthPartners Institute

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

  • Negative pressure wound therapy
  • NPWT
  • NPWTi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HealthPartners Institute on 2025-09-17.