Pressure Sore
Conditions
Brief summary
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.
Interventions
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.
OTHERStandard of Care (Wet-to-dry dressings)
Wet-to-dry dressings
Sponsors
Northwestern University
3M
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ischial and sacral wounds at stage 3 and 4. 2. Any pressure sore that has the potential for a good seal.
Exclusion criteria
1. Any pressure sore that does not have potential for a good seal. 2. Patients with fecal incontinence (due to potential for pressure sore to be near the anus). 3. Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.). 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Length of Stay | up to 3 months | Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Analysis | Through study completion, approximately 5 months | Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care. |
| Number of debridements | Through study completion, approximately 5 months | Record the total number of debridements performed at the wound site throughout the duration of the study |
| Successful closure of pressure sores | 2 weeks and 6 weeks post-closure surgery | Patients will be assessed for proper closure of the wound |
Countries
United States
Contacts
CONTACTRobert Galiano, MD
CONTACTKristin Huffman, B.S.
PRINCIPAL_INVESTIGATORRobert Galiano, MD
Northwestern University
Outcome results
None listed