Status:
COMPLETED
SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
University of Iowa
University of Maryland
Conditions:
Surgical Site Infection
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
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 an...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
3680 Patients enrolled
Trial Details
Trial ID
NCT03816293
Start Date
May 1 2019
End Date
September 30 2021
Last Update
November 21 2022
Active Locations (5)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
2
Emory University
Atlanta, Georgia, United States, 30322
3
University of Illinois Hospital
Chicago, Illinois, United States, 60612
4
University of Iowa Health System
Iowa City, Iowa, United States, 52242