RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Instillation vs Traditional Negative Pressure Wound Therapy: A Pilot Randomized Controlled Trial for Necrotizing Soft Tissue Infections (NPWTi-NSTI Trial)

Quick Facts

Study Start:2025-08-01
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07120386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention
  2. * Age \>/=18 years old
  3. * Planned application of a negative pressure wound dressing
  1. * Patients who have a wound that does not allow for a wound vac
  2. * Patients receiving acute treatment for a NSTI at another institution
  3. * Incarcerated patients
  4. * Patients who do not survive to wound closure/coverage
  5. * Patients \<18 years old

Contacts and Locations

Study Contact

Nicholas J Larson
CONTACT
651-254-4846
RegionsSurgicalResearch@HealthPartners.com

Principal Investigator

Brian S Myer, MD
PRINCIPAL_INVESTIGATOR
Regions Hospital

Study Locations (Sites)

Regions Hospital
Saint Paul, Minnesota, 55101
United States

Collaborators and Investigators

Sponsor: HealthPartners Institute

  • Brian S Myer, MD, PRINCIPAL_INVESTIGATOR, Regions Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Negative pressure wound therapy
  • NPWT
  • NPWTi

Additional Relevant MeSH Terms

  • Necrotizing Soft Tissue Infections