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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes; Cesarean Section Complications; Surgical Site Infection
• Intervention / Treatment: Device: Negative Pressure Wound Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 3680
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Health System
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Negative Pressure Wound Therapy; Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions; Other Names: Prevena Incision Management
No Intervention: Control Dressing; 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?

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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: University of Maryland; University of Iowa; Emory University; Centers for Disease Control and Prevention; Acelity
• Investigators: Principal Investigator: Susan Bleasdale, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: abdominal hysterectomy; colon surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: 2018-1300; U01CK000557-01-00 (Other Grant/Funding Number: CDC); U01CK000557-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is a study with waiver of consent data will be in aggregate without patient identifiers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes