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

Obesity Clinical Trial

— SUpPressSSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816293
• Other study ID #: 2018-1300
• Secondary ID: U01CK000557-01-0
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3680
• Est. completion date: September 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Communicable Diseases
• Diabetes
• Infections
• Obesity
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Negative Pressure Wound Therapy
Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	University of Illinois Hospital	Chicago	Illinois
United States	University of Iowa Health System	Iowa City	Iowa

Sponsors (6)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Acelity, Centers for Disease Control and Prevention, Emory University, University of Iowa, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection Rate per 100 surgeries	Superficial , Deep and organ space infections after surgery	within 30 days after surgery
Secondary	Post Operative Length of Stay (days)	days of ongoing admission after surgery	within 30days after surgery
Secondary	REadmission incidence and rate per 100 surgeries	REadmission to hospital after discharge from surgery	within 30 days
Secondary	Seroma incidence and rate per 100 surgeries	Non infectious Fluid accumulation	with in 30 days after surgery
Secondary	Hematoma incidence and rate per 100 surgeries	Bloody fluid collection	within 30 days after surgery
Secondary	Dehiscence incidence and rate per 100 surgeries	Loss of incision apposition	within 30 days after surgery