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

Not Applicable

Completed

• Conditions: Surgical Site Infection; Diabetes; Obesity; Cesarean Section Complications
• Interventions: Device: Negative Pressure Wound Therapy

• Registration Number: NCT03816293
• Lead Sponsor: University of Illinois at Chicago

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.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-25
• Study Start: 2019-05-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3680

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy	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

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection Rate per 100 surgeries	within 30 days after surgery	Superficial , Deep and organ space infections after surgery

Secondary Outcome Measures

Name	Time	Method
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
Dehiscence incidence and rate per 100 surgeries	within 30 days after surgery	Loss of incision apposition
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

Trial Locations

Locations (5)

University of Illinois Hospital; 🇺🇸 Chicago, Illinois, United States

University of Iowa Health System; 🇺🇸 Iowa City, Iowa, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States