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| ID | Type | Description | Link |
|---|---|---|---|
| 0002758892 | Other Grant/Funding Number | University of Minnesota Translational Center for Resuscitative Trauma Care |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Active Comparator | Patients in this arm will receive traditional Negative Pressure Wound Therapy (NPWT) |
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| Negative Pressure Wound Therapy with Instillation | Experimental | Patients in this arm will receive Negative Pressure Wound Therapy with Instillation of a hypochlorous acid solution (NPWTi) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | NPWT creates a vacuum seal over your wound to promote healing |
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| Measure | Description | Time Frame |
|---|---|---|
| Unplanned hospital readmission | Did the patient have an unplanned readmission to the hospital (Y/N) within 30 days of discharge | Within 30 days of discharge |
| Rate of healing | Time from index debridement to final coverage in days | First operation and last operation |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of operative interventions | Number of times the patient required an operation related to their NSTI during their hospital stay | Through hospital discharge, median of 9 days |
| Unplanned vac change |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicholas J Larson | Contact | 651-254-4846 | RegionsSurgicalResearch@HealthPartners.com |
| Name | Affiliation | Role |
|---|---|---|
| Brian S Myer, MD | Regions Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Recruiting | Saint Paul | Minnesota | 55101 | United States |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| 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. |
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Number of unplanned times the vacuum dressing had to be changed during their hospital stay
| Through hospital discharge, median of 9 days |
| Total vac changes | Total number of times the vacuum dressing was changed (planned + unplanned) during their hospital stay | Through hospital discharge, median of 9 days |
| Bleeding | Bleeding at wound vac site (Y/N). During hospital stay | Through hospital discharge, median of 9 days |
| Infection | New infection at wound vac site (Y/N). During hospital stay | Through hospital discharge, median of 9 days |
| Hospital length of stay | Number of days spent in Hospital | At hospital discharge, median of 9 days |
| Intensive Care Unit length of stay | Number of days spent in the Intensive Care Unit | At hospital discharge, median of 9 days |
| Floor length of stay | Number of days spent inpatient in the hospital | At hospital discharge, median of 9 days |
| Skilled Nursing Facility days | Number of days spent in a skilled nursing facility | Up to 6 months after admission to skilled nursing facility |
| Discharge disposition | "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""" | At hospital discharge, median of 9 days |