Surgical Site InfectionSUpPressSSINCT03816293
SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections
A study testing Negative Pressure Wound Therapy in people with Surgical Site Infection and Obesity, run by University of Illinois Chicago at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Obesity, Diabetes
- What is being tested?
- Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,680 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 May 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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).
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
University of Illinois Hospital
Chicago, Illinois, 60612
University of Iowa Health System
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Being tested
- Negative Pressure Wound Therapy
- Keywords
- colon surgery, abdominal hysterectomy
- Medical subject headings
- Surgical Wound Infection, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Also called Prevena Incision Management
Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | NPWT use on closed incision for 7 days after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity Receives: Device: Negative Pressure Wound Therapy |
| Control Dressing | No intervention | Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection Rate per 100 surgeries
Superficial , Deep and organ space infections after surgery
Measured: within 30 days after surgery
Secondary outcomes (5)
Post Operative Length of Stay (days)
days of ongoing admission after surgery
Measured: within 30days after surgery
REadmission incidence and rate per 100 surgeries
REadmission to hospital after discharge from surgery
Measured: within 30 days
Seroma incidence and rate per 100 surgeries
Non infectious Fluid accumulation
Measured: with in 30 days after surgery
Hematoma incidence and rate per 100 surgeries
Bloody fluid collection
Measured: within 30 days after surgery
Dehiscence incidence and rate per 100 surgeries
Loss of incision apposition
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 May 2019
- Primary completion31 Mar 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized stepped wedge cluster but site
- Masking
- None (open label)
- Enrolment
- 3,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Maryland, Emory University, Centers for Disease Control and Prevention, Acelity
- Responsible party
- Principal investigator, Susan Casey Bleasdale, University of Illinois Chicago
- Investigators
- Susan Bleasdale, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816293
- Sponsor's protocol ID
- 2018-1300
- Other IDs
- U01CK000557-01-00, U01CK000557-01
- Acronym
- SUpPressSSI
- Status last verified
- Nov 2022
- First submitted
- 22 Jan 2019
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a study with waiver of consent data will be in aggregate without patient identifiers
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections
- ClinicalTrials.gov ID
- NCT03816293
- Acronym / sponsor ID
- SUpPressSSI / 2018-1300
- Keywords
- colon surgery, abdominal hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,680 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- University of Iowa, University of Maryland, Emory University, Centers for Disease Control and Prevention, Acelity
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized stepped wedge cluster but site
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Device: Negative Pressure Wound TherapyNPWT use on closed incision for 7 days after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity |
| Control Dressing | No intervention | –Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- and either of the following medical conditions:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyAlso: Prevena Incision ManagementOcclusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions | Device | Negative Pressure Wound Therapy |
Primary outcome
Surgical Site Infection Rate per 100 surgeries
Time frame: within 30 days after surgery
Superficial , Deep and organ space infections after surgery
5 secondary outcomes
Post Operative Length of Stay (days)
Time frame: within 30days after surgery
REadmission incidence and rate per 100 surgeries
Time frame: within 30 days
Seroma incidence and rate per 100 surgeries
Time frame: with in 30 days after surgery
Hematoma incidence and rate per 100 surgeries
Time frame: within 30 days after surgery
Dehiscence incidence and rate per 100 surgeries
Time frame: within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No. This is a study with waiver of consent data will be in aggregate without patient identifiers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Bleasdale, MD principal investigator
University of Illinois Chicago
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy in people with Surgical Site Infection and Obesity, run by University of Illinois Chicago at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection Rate per 100 surgeries (time frame: within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.