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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
The V.A.C.Ulta™ Negative Pressure Wound Therapy System is a 510(k) - cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ulta™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Wet-to-dry dressings
Northwestern University
Chicago, Illinois, United States
RECRUITINGTotal Length of Stay
Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery
Time frame: up to 3 months
Cost Analysis
Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.
Time frame: Through study completion, approximately 5 months
Number of debridements
Record the total number of debridements performed at the wound site throughout the duration of the study
Time frame: Through study completion, approximately 5 months
Successful closure of pressure sores
Patients will be assessed for proper closure of the wound
Time frame: 2 weeks and 6 weeks post-closure surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.