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

NCT ID: NCT03816293

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-09-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Negative Pressure Wound Therapy

Intervention Type: DEVICE

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

Control Dressing

Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Negative Pressure Wound Therapy

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

Intervention Type: DEVICE

Other Intervention Names

Prevena Incision Management

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Acelity

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Susan Casey Bleasdale

Associate Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Bleasdale, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

University of Illinois Hospital

Chicago, Illinois, United States

University of Iowa Health System

Iowa City, Iowa, United States

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

U01CK000557-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U01CK000557-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-1300

Identifier Type: -

Identifier Source: org_study_id