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

Recruiting now · Not applicable

Conditions studied: Necrotizing Soft Tissue Infections

In brief

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.

Key facts

Study ID

NCT07120386

Run by

HealthPartners Institute

People needed

30

Starts

2025-08-01

Expected to finish

2026-10-01

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention
• Age >/=18 years old
• Planned application of a negative pressure wound dressing

You may not qualify if…

• 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

Where it is running

• Regions Hospital — Saint Paul, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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