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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHealthPartners Institute

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention

Age >/=18 years old

Planned application of a negative pressure wound dressing

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Negative Pressure Wound Therapy

    Device

    NPWT creates a vacuum seal over your wound to promote healing

  • Negative Pressure Wound Therapy with Instillation

    Device

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Negative Pressure Wound TherapyActive comparator 1 intervention
Group B: Negative Pressure Wound Therapy with InstillationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Unplanned hospital readmission

Did the patient have an unplanned readmission to the hospital (Y/N) within 30 days of discharge

Time frame
Within 30 days of discharge
2

Rate of healing

Time from index debridement to final coverage in days

Time frame
First operation and last operation

Secondary outcomes

Other outcomes

1

Number of operative interventions

Number of times the patient required an operation related to their NSTI during their hospital stay

Time frame
Through hospital discharge, median of 9 days
2

Unplanned vac change

Number of unplanned times the vacuum dressing had to be changed during their hospital stay

Time frame
Through hospital discharge, median of 9 days
3

Total vac changes

Total number of times the vacuum dressing was changed (planned + unplanned) during their hospital stay

Time frame
Through hospital discharge, median of 9 days
4

Bleeding

Bleeding at wound vac site (Y/N). During hospital stay

Time frame
Through hospital discharge, median of 9 days

Sponsors and contacts

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HealthPartners Institute

Lead sponsor

University of Minnesota

Collaborator