Cesarean Section Complications, Diabetes, Obesity, Surgical Site Infection
Conditions
Keywords
colon surgery, abdominal hysterectomy
Brief summary
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
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.
Interventions
DEVICENegative Pressure Wound Therapy
Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions
Sponsors
University of Iowa
University of Maryland
Emory University
Centers for Disease Control and Prevention
Acelity
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized stepped wedge cluster but site
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Category A and B A. Patients undergoing any of the below procedures: 1. C-section 2. abdominal hysterectomy 3. 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: 1. obesity, BMI \>30 kg/m2 2. 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
1. Age less than 18 years 2. Infection present at the time of the surgery 3. Laparoscopic procedures with incisions \<6cm. 4. Patients using alternative NPWT device other than the PrevenaTM with 125 mm Hg negative pressure 5. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection Rate per 100 surgeries | within 30 days after surgery | Superficial , Deep and organ space infections after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Length of Stay (days) | within 30days after surgery | days of ongoing admission after surgery |
| REadmission incidence and rate per 100 surgeries | within 30 days | REadmission to hospital after discharge from surgery |
| Seroma incidence and rate per 100 surgeries | with in 30 days after surgery | Non infectious Fluid accumulation |
| Hematoma incidence and rate per 100 surgeries | within 30 days after surgery | Bloody fluid collection |
| Dehiscence incidence and rate per 100 surgeries | within 30 days after surgery | Loss of incision apposition |
Countries
United States
Outcome results
None listed