Necrotizing Soft Tissue InfectionsNPWT-NSTINCT07120386
Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
A study testing Negative Pressure Wound Therapy and Negative Pressure Wound Therapy with Instillation in people with Necrotizing Soft Tissue Infections, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Soft Tissue Infections
- What is being tested?
- Negative Pressure Wound Therapy and Negative Pressure Wound Therapy with Instillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention
- Age >/=18 years old
- Planned application of a negative pressure wound dressing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Nicholas J Larson, 651-254-4846, RegionsSurgicalResearch@HealthPartners.com
Brian S Myer, MD
About this study
Official title: 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.
- Conditions
- Necrotizing Soft Tissue Infections
- Being tested
- Negative Pressure Wound Therapy, Negative Pressure Wound Therapy with Instillation
- Keywords
- Negative pressure wound therapy, NPWT, NPWTi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Also called NPWT
NPWT creates a vacuum seal over your wound to promote healing
Negative Pressure Wound Therapy with InstillationDevice
Also called NPWTi
NPWTi creates a vacuum seal over your wound and infuses the wound with hypochlorous acid (medical grade dilute bleach) to clean it.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Patients in this arm will receive traditional Negative Pressure Wound Therapy (NPWT) Receives: 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) Receives: Device: Negative Pressure Wound Therapy with Instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned hospital readmission
Did the patient have an unplanned readmission to the hospital (Y/N) within 30 days of discharge
Measured: Within 30 days of discharge
Rate of healing
Time from index debridement to final coverage in days
Measured: First operation and last operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Soft Tissue InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Brian S Myer, MD, Principal investigator, Regions Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120386
- Sponsor's protocol ID
- A24-205
- Other IDs
- 0002758892
- Acronym
- NPWT-NSTI
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instillation vs Traditional Negative Pressure Wound Therapy: A Pilot Randomized Controlled Trial for Necrotizing Soft Tissue Infections (NPWTi-NSTI Trial)
- ClinicalTrials.gov ID
- NCT07120386
- Acronym / sponsor ID
- NPWT-NSTI / A24-205
- Conditions
- Necrotizing Soft Tissue Infections
- Keywords
- Negative pressure wound therapy, NPWT, NPWTi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Device: Negative Pressure Wound TherapyPatients in this arm will receive traditional Negative Pressure Wound Therapy (NPWT) |
| Negative Pressure Wound Therapy with Instillation | Experimental | Device: Negative Pressure Wound Therapy with InstillationPatients in this arm will receive Negative Pressure Wound Therapy with Instillation of a hypochlorous acid solution (NPWTi) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention
- Age >/=18 years old
- Planned application of a negative pressure wound dressing
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyAlso: NPWTNPWT creates a vacuum seal over your wound to promote healing | Device | Negative Pressure Wound Therapy |
| Negative Pressure Wound Therapy with InstillationAlso: NPWTiNPWTi creates a vacuum seal over your wound and infuses the wound with hypochlorous acid (medical grade dilute bleach) to clean it. | Device | Negative Pressure Wound Therapy with Instillation |
Primary outcome
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
Rate of healing
Time frame: First operation and last operation
Time from index debridement to final coverage in days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian S Myer, MD principal investigator
Regions Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Negative Pressure Wound Therapy with Instillation in people with Necrotizing Soft Tissue Infections, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas J Larson (651-254-4846, RegionsSurgicalResearch@HealthPartners.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned hospital readmission (time frame: Within 30 days of discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.