Irrigating versus traditional negative-pressure wound therapy for necrotizing soft tissue infections
Instillation vs Traditional Negative Pressure Wound Therapy: A Pilot Randomized Controlled Trial for Necrotizing Soft Tissue Infections (NPWTi-NSTI Trial)
This tests whether irrigating negative-pressure wound therapy (NPWTi) or traditional NPWT works better for adults with necrotizing soft tissue infections who need surgical wound care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HealthPartners Institute Academic / other |
| Locations | 1 site (Saint Paul, Minnesota) |
| Trial ID | NCT07120386 on ClinicalTrials.gov |
What this trial studies
Adults with clinical suspicion for necrotizing soft tissue infection who undergo emergent surgical debridement and will receive a negative-pressure wound dressing are enrolled at Regions Hospital in Saint Paul, Minnesota. Participants receive either traditional negative-pressure wound therapy or negative-pressure wound therapy with periodic irrigation as part of their postoperative wound management. The trial compares the two approaches using clinical wound outcomes such as wound cleaning, complications, and time to closure while excluding patients treated acutely at other institutions or whose wounds cannot accept a wound vac. The protocol excludes minors, incarcerated patients, and patients who do not survive to wound closure or coverage.
Who should consider this trial
Good fit: Adults aged 18 or older with clinical suspicion of necrotizing soft tissue infection requiring emergent operative debridement and planned application of a negative-pressure wound dressing are ideal candidates.
Not a fit: Patients whose wounds cannot accommodate a wound vac, those receiving acute NSTI treatment at another institution, incarcerated individuals, minors, or patients who do not survive to wound closure are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the irrigating approach could reduce wound contamination and complications and help wounds close faster, lowering morbidity and the need for repeat operations.
How similar studies have performed: Traditional NPWT is well established and NPWT with instillation is used in practice, but there are limited direct comparative data between the two approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint Paul, Minnesota
- Regions Hospital — Saint Paul, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Brian S Myer, MD — Regions Hospital
- Study coordinator: Nicholas J Larson
- Email: RegionsSurgicalResearch@HealthPartners.com
- Phone: 651-254-4846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.