Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections (NPWT-NSTI)

HealthPartners Institute

Status: Enrolling

Conditions: Necrotizing Soft Tissue Infections

Treatments: Device: Negative Pressure Wound Therapy; Device: Negative Pressure Wound Therapy with Instillation

Study type: Interventional

Funder types: Other

Identifiers

NCT07120386

0002758892 (Other Grant/Funding Number)

A24-205

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Negative Pressure Wound Therapy

Active Comparator group

Description:

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

Treatment:

Device: Negative Pressure Wound Therapy

Negative Pressure Wound Therapy with Instillation

Experimental group

Description:

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

Treatment:

Device: Negative Pressure Wound Therapy with Instillation