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

Overview

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.

Full Title of Study: “SUpPress SSI – Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2021

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

  • Device: Negative Pressure Wound Therapy
    • Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions

Arms, Groups and Cohorts

  • Active Comparator: Negative Pressure Wound Therapy
    • NPWT use on closed incision for 7 days after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity
  • No Intervention: Control Dressing
    • Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity

Clinical Trial Outcome Measures

Primary Measures

  • Surgical Site Infection Rate per 100 surgeries
    • Time Frame: within 30 days after surgery
    • Superficial , Deep and organ space infections after surgery

Secondary Measures

  • Post Operative Length of Stay (days)
    • Time Frame: within 30days after surgery
    • days of ongoing admission after surgery
  • REadmission incidence and rate per 100 surgeries
    • Time Frame: within 30 days
    • REadmission to hospital after discharge from surgery
  • Seroma incidence and rate per 100 surgeries
    • Time Frame: with in 30 days after surgery
    • Non infectious Fluid accumulation
  • Hematoma incidence and rate per 100 surgeries
    • Time Frame: within 30 days after surgery
    • Bloody fluid collection
  • Dehiscence incidence and rate per 100 surgeries
    • Time Frame: within 30 days after surgery
    • Loss of incision apposition

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Illinois at Chicago
  • Collaborator
    • University of Iowa
  • Provider of Information About this Clinical Study
    • Principal Investigator: Susan Casey Bleasdale, Associate Professor of Clinical Medicine – University of Illinois at Chicago
  • Overall Official(s)
    • Susan Bleasdale, MD, Principal Investigator, University of Illinois at Chicago

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