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

NCT03816293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3680

Last updated 2022-11-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Negative Pressure Wound Therapy

Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • University of Maryland

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Centers for Disease Control and Prevention

    collaborator FED

  • Acelity

    collaborator OTHER

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Susan Bleasdale, MD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-03-31
Completion
2021-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816293 on ClinicalTrials.gov