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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Wet-to-dry dressings) | Active Comparator | Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore. |
|
| Treatment (NPWT with Instillation) | Experimental | Subjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFloâ„¢ Cleanse Choice Dressing Systems for treatment of their pressure sore. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V.A.C.Ultaâ„¢ Negative Pressure Wound Therapy System | Device | The V.A.C.Ultaâ„¢ Negative Pressure Wound Therapy System is a 510(k) - cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ultaâ„¢ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. |
| Measure | Description | Time Frame |
|---|---|---|
| Total 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 | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost Analysis | Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care. | Through study completion, approximately 5 months |
| Number of debridements |
| Measure | Description | Time Frame |
|---|---|---|
| Proteomic analysis | Amount of bacteria present in frozen tissue that was collected at treatment day 1 will be determined and compared between groups using a two sample t-test. | 1 year post-closure surgery |
| Bioburden assessment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Galiano, MD | Contact | 3129267037 | robert.galiano@nm.org | |
| Kristin Huffman, B.S. | Contact | 3129267037 | kristin.huffman@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Galiano, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care (Wet-to-dry dressings) | Other | Wet-to-dry dressings |
|
Record the total number of debridements performed at the wound site throughout the duration of the study
| Through study completion, approximately 5 months |
| Successful closure of pressure sores | Patients will be assessed for proper closure of the wound | 2 weeks and 6 weeks post-closure surgery |
Photos of the wound will be taken with a specialized bioburden camera, which can pick up on bacterial load of the wound. Photos will be taken before debridement, after debridement, after every dressing change, and on the day of surgery.
| Through study completion, approximately 5 months |
| Wound characteristic assessments | Wound characteristics collected by the 3D imaging as well as bioburden collected by the bioburden camera will be compared between the control and study groups. Each respective comparison will involve 2 independent sample t-tests. | 1 year post-closure surgery |