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Completed

NCT Number: NCT03816293

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

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.

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Key information

Conditions

Surgical Site Infection Body Weight Cesarean Section Complications Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative pressure wound therapy

Device

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

Other names: Prevena Incision Management

Primary outcomes

  1. Surgical Site Infection Rate per 100 surgeries

    Time frame: within 30 days after surgery

    Superficial , Deep and organ space infections after surgery

Secondary outcomes

  1. Post Operative Length of Stay (days)

    Time frame: within 30days after surgery

    days of ongoing admission after surgery

  2. REadmission incidence and rate per 100 surgeries

    Time frame: within 30 days

    REadmission to hospital after discharge from surgery

  3. Seroma incidence and rate per 100 surgeries

    Time frame: with in 30 days after surgery

    Non infectious Fluid accumulation

  4. Hematoma incidence and rate per 100 surgeries

    Time frame: within 30 days after surgery

    Bloody fluid collection

  5. Dehiscence incidence and rate per 100 surgeries

    Time frame: within 30 days after surgery

    Loss of incision apposition

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Acelity
  • Centers for Disease Control and Prevention
  • Emory University
  • University of Iowa
  • University of Maryland

Registry information

Acronym: SUpPressSSI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2019
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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