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NCT Number: NCT07120386

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

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.

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Key information

Conditions

Necrotizing Soft Tissue Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location status: Recruiting

Location contact

Brian S Myer, MD

PRINCIPAL_INVESTIGATOR

Nicholas J Larson

CONTACT

[email protected]

651-254-4846

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative pressure wound therapy

Device

NPWT creates a vacuum seal over your wound to promote healing

Other names: NPWT

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.

Other names: NPWTi

Primary outcomes

  1. Unplanned hospital readmission

    Time frame: Within 30 days of discharge

    Did the patient have an unplanned readmission to the hospital (Y/N) within 30 days of discharge

  2. Rate of healing

    Time frame: First operation and last operation

    Time from index debridement to final coverage in days

Other outcomes

  1. Number of operative interventions

    Time frame: Through hospital discharge, median of 9 days

    Number of times the patient required an operation related to their NSTI during their hospital stay

  2. Unplanned vac change

    Time frame: Through hospital discharge, median of 9 days

    Number of unplanned times the vacuum dressing had to be changed during their hospital stay

  3. Total vac changes

    Time frame: Through hospital discharge, median of 9 days

    Total number of times the vacuum dressing was changed (planned + unplanned) during their hospital stay

  4. Bleeding

    Time frame: Through hospital discharge, median of 9 days

    Bleeding at wound vac site (Y/N). During hospital stay

  5. Infection

    Time frame: Through hospital discharge, median of 9 days

    New infection at wound vac site (Y/N). During hospital stay

  6. Hospital length of stay

    Time frame: At hospital discharge, median of 9 days

    Number of days spent in Hospital

  7. Intensive Care Unit length of stay

    Time frame: At hospital discharge, median of 9 days

    Number of days spent in the Intensive Care Unit

  8. Floor length of stay

    Time frame: At hospital discharge, median of 9 days

    Number of days spent inpatient in the hospital

  9. Skilled Nursing Facility days

    Time frame: Up to 6 months after admission to skilled nursing facility

    Number of days spent in a skilled nursing facility

  10. Discharge disposition

    Time frame: At hospital discharge, median of 9 days

    "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"""

Study contacts

Contact information is provided by the study sponsor or research team.

Nicholas J Larson

CONTACT

[email protected]

651-254-4846

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • University of Minnesota

Registry information

Official study title

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

Acronym: NPWT-NSTI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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