SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections

Conditions
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Surgical Site Infection, Obesity, Diabetes, Cesarean Section Complications

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Category A and B A. Patients undergoing any of the below procedures: C-section abdominal hysterectomy colon procedures Surgical procedures selected will be based on NHSN designated ICD-10 PCS codes(14), with the exclusion of laparoscopic procedures. B. and either of the following medical conditions: obesity, BMI >30 kg/m2 diabetes type 1 or 2 Criteria for a diagnosis of diabetes: Diabetes noted in the problem list or the medical history or Patient is taking a medication as treatment for diabetes, consistent with NHSN criteria(10). Exclusion Criteria: Age less than 18 years Infection present at the time of the surgery Laparoscopic procedures with incisions <6cm. Patients using alternative NPWT device other than the PrevenaTM with 125 mm Hg negative pressure Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized stepped wedge cluster but site
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Negative Pressure Wound Therapy<br>NPWT use on closed incision for 7 days after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity | Device: Negative Pressure Wound Therapy<br>* Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions<br>* Other names: Prevena Incision Management;|
| No Intervention: Control Dressing<br>Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection Rate per 100 surgeries | Superficial , Deep and organ space infections after surgery | within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon surgery, abdominal hysterectomy