Clinical trial NCT03816293: SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections
Official title: SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Obesity
Diabetes
Cesarean Section Complications
Keywords: colon surgery
abdominal hysterectomy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: University of Maryland
name: Emory University
name: Centers for Disease Control and Prevention
name: Acelity
First posted: 2019-01-25
Enrollment: 3680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized stepped wedge cluster but site
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical Site Infection Rate per 100 surgeries
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: Post Operative Length of Stay (days)
timeFrame: within 30days after surgery
measure: REadmission incidence and rate per 100 surgeries
timeFrame: within 30 days
measure: Seroma incidence and rate per 100 surgeries
timeFrame: with in 30 days after surgery
measure: Hematoma incidence and rate per 100 surgeries
timeFrame: within 30 days after surgery
measure: Dehiscence incidence and rate per 100 surgeries
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Health System
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Illinois at Chicago
name: Susan Bleasdale, MD
role: PRINCIPAL_INVESTIGATOR
References: