Necrotizing Soft Tissue Infections
Conditions
Keywords
Negative pressure wound therapy, NPWT, NPWTi
Brief summary
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.
Interventions
DEVICENegative Pressure Wound Therapy
NPWT creates a vacuum seal over your wound to promote healing
DEVICENegative 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.
Sponsors
University of Minnesota
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned hospital readmission | Within 30 days of discharge | Did the patient have an unplanned readmission to the hospital (Y/N) within 30 days of discharge |
| Rate of healing | First operation and last operation | Time from index debridement to final coverage in days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total vac changes | Through hospital discharge, median of 9 days | Total number of times the vacuum dressing was changed (planned + unplanned) during their hospital stay |
| Bleeding | Through hospital discharge, median of 9 days | Bleeding at wound vac site (Y/N). During hospital stay |
| Infection | Through hospital discharge, median of 9 days | New infection at wound vac site (Y/N). During hospital stay |
| Hospital length of stay | At hospital discharge, median of 9 days | Number of days spent in Hospital |
| Number of operative interventions | Through hospital discharge, median of 9 days | Number of times the patient required an operation related to their NSTI during their hospital stay |
| Floor length of stay | At hospital discharge, median of 9 days | Number of days spent inpatient in the hospital |
| Skilled Nursing Facility days | Up to 6 months after admission to skilled nursing facility | Number of days spent in a skilled nursing facility |
| Discharge disposition | At hospital discharge, median of 9 days | Where was the patient discharged: 1=Discharged/Transferred to a short-term general hospital for inpatient care 2=Discharged/Transferred to an Intermediate Care Facility (ICF) 3=Discharged/Transferred to home under care of organized home health service 4=Left against medical advice or discontinued care 5=Deceased/Expired 6=Discharged to home or self-care (routine discharge) 7=Discharged/Transferred to Skilled Nursing Facility (SNF) 8=Discharged/Transferred to hospice care 9=Discharged/Transferred to court/law enforcement. 10=Discharged/Transferred to inpatient rehab or designated unit 11=Discharged/Transferred to Long Term Care Hospital (LTCH) 12=Discharged/Transferred to a psychiatric hospital or psychiatric distinct part unit of a hospital 13=Discharged/Transferred to another type of institution not defined elsewhere |
| Intensive Care Unit length of stay | At hospital discharge, median of 9 days | Number of days spent in the Intensive Care Unit |
| Unplanned vac change | Through hospital discharge, median of 9 days | Number of unplanned times the vacuum dressing had to be changed during their hospital stay |
Countries
United States
Contacts
Primary ContactNicholas J Larson
Outcome results
None listed