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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Necrotizing Soft Tissue Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Negative Pressure Wound Therapy

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

Group Type ACTIVE_COMPARATOR

Negative Pressure Wound Therapy

Intervention Type DEVICE

NPWT creates a vacuum seal over your wound to promote healing

Negative Pressure Wound Therapy with Instillation

Patients in this arm will receive Negative Pressure Wound Therapy with Instillation of a hypochlorous acid solution (NPWTi)

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy with Instillation

Intervention Type DEVICE

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

Interventions

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Negative Pressure Wound Therapy

NPWT creates a vacuum seal over your wound to promote healing

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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NPWT NPWTi

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No