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| ID | Type | Description | Link |
|---|---|---|---|
| U01CK000557-01-00 | Other Grant/Funding Number | CDC | |
| U01CK000557-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| University of Maryland | OTHER |
| Emory University | OTHER |
| Centers for Disease Control and Prevention |
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Our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. We also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to NPWT use. Additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the NPWT.
Specific Aim 1: Evaluate the effect of single-use NPWT on SSI rates after C-section, abdominal hysterectomy, and colon procedures in at risk patients.
To address this aim, we will conduct multicenter, stepped-wedge, quasi-experimental trial evaluating use of the PrevenaTM with 125 mm Hg negative pressure for 7 days among obese (BMI >30) and/or diabetic patients undergoing the procedures of interest. This is essentially a phase IV clinical trial as this dressing has FDA approval for the indicated use.
Specific Aim 2: Investigate the patients' experience of using the NPWT. To achieve this aim, we will survey a sub-set of patients to assess their knowledge of post-operative care, to identify complications associated with NPWT use, and to learn how patients evaluated the device's ease of use, ease of removal, and comfort.
Specific Aim 3: Assess whether real-time decision support through machine-learning modeling can help surgeons identify patients at high risk of SSI who could benefit from NWPT or other post-surgical preventive measures. To address this aim, we will evaluate whether boosted tree modeling techniques can be used "at the bedside" via electronic medical record data feeds to tailor post-operative care and preventive care for specific patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Active Comparator | NPWT use on closed incision for 7 days after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity |
|
| Control Dressing | No Intervention | Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions |
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| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection Rate per 100 surgeries | Superficial , Deep and organ space infections after surgery | within 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Length of Stay (days) | days of ongoing admission after surgery | within 30days after surgery |
| REadmission incidence and rate per 100 surgeries | REadmission to hospital after discharge from surgery |
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Inclusion Criteria: Category A and B
A. Patients undergoing any of the below procedures:
B. and either of the following medical conditions:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Bleasdale, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University |
This is a study with waiver of consent data will be in aggregate without patient identifiers
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| FED |
| Acelity | OTHER |
Randomized stepped wedge cluster but site
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| within 30 days |
| Seroma incidence and rate per 100 surgeries | Non infectious Fluid accumulation | with in 30 days after surgery |
| Hematoma incidence and rate per 100 surgeries | Bloody fluid collection | within 30 days after surgery |
| Dehiscence incidence and rate per 100 surgeries | Loss of incision apposition | within 30 days after surgery |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Illinois Hospital | Chicago | Illinois | 60612 | United States |
| University of Iowa Health System | Iowa City | Iowa | 52242 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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