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

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03816293

Collaborator

University of Iowa (Other), University of Maryland, College Park (Other), Emory University (Other), Centers for Disease Control and Prevention (U.S. Fed), Acelity (Other)

3,650

Enrollment

Locations

Arms

23.5

Anticipated Duration (Months)

730

Patients Per Site

31.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection Obesity Diabetes Cesarean Section Complications	Device: Negative Pressure Wound Therapy	N/A

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3650 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Randomized stepped wedge cluster but siteRandomized stepped wedge cluster but site

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Apr 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Surgical Site Infection Rate per 100 surgeries [within 30 days after surgery]
Superficial , Deep and organ space infections after surgery

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: 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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	University of Maryland	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

University of Illinois at Chicago
University of Iowa
University of Maryland, College Park
Emory University
Centers for Disease Control and Prevention
Acelity

Investigators

Principal Investigator: Susan Bleasdale, MD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Susan Casey Bleasdale, Associate Professor of Clinical Medicine, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT03816293

Other Study ID Numbers:

2018-1300

First Posted:

Jan 25, 2019

Last Update Posted:

Feb 11, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Susan Casey Bleasdale, Associate Professor of Clinical Medicine, University of Illinois at Chicago

colon surgery

abdominal hysterectomy

Additional relevant MeSH terms:

Infections

Communicable Diseases

Surgical Wound Infection

Study Results

No Results Posted as of Feb 11, 2021