NCT03816293

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,680 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection
• Obesity
• Diabetes
• Cesarean Section Complications

Interventions

Type	Name	Description
DEVICE	Negative Pressure Wound Therapy	Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-03-31
• Completion: 2021-09-30
• First posted: 2019-01-25
• Last updated: 2022-11-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study