NPWTi on Closure of Chronic Pressure Sores
ConditionPressure Sore
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.
Eligibility criteria
Qualifiers
Ischial and sacral wounds at stage 3 and 4.
Any pressure sore that has the potential for a good seal.
Disqualifiers
Any pressure sore that does not have potential for a good seal.
Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.
Trial design
Treatments tested in this trial
- V.A.C.Ulta™ Negative Pressure Wound Therapy System
- Standard of Care (Wet-to-dry dressings)
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Northwestern University
Lead sponsor
3M
Collaborator
Source ClinicalTrials.gov