Surgical Wound InfectionNCT02020018
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection
A study testing Prevena Incision Management System and Conventional sterile dry wound dressing in people with Surgical Wound Infection, run by Mayo Clinic at 1 site in United States.
Trial summary
This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Prevena Incision Management System and Conventional sterile dry wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,869 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Transplant patients
- BMI >30
- Type I (insulin-dependent) diabetics
- Severe chronic obstructive pulmonary disease (COPD)
- Steroid-dependent patients
- Previous Tracheostomy
Who cannot join
- BMI<30
- Thoracotomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery
This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.
Read the detailed description
Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.
- Conditions
- Surgical Wound Infection
- Being tested
- Prevena Incision Management System, Conventional sterile dry wound dressing
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena Incision Management SystemDevice
Also called negative pressure therapy, wound VAC, Prevena
negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days
Conventional sterile dry wound dressingOther
Also called poststernotomy wound dressing, standard dressing after sternotomy
regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy
| Study group | Role | What they receive |
|---|---|---|
| Prospective group | Experimental | Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively. Receives: Device: Prevena Incision Management System |
| Retrospective arm | Active comparator | Conventional sterile dry wound dressing applied immediately postoperatively. Receives: Other: Conventional sterile dry wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Infection After Open Heart Surgery
The total number of participants with surgical site infections after cardiac surgery.
Measured: 30 days post-surgery
Secondary outcomes (1)
Reoperation for Wound Infection
The total number of reoperations required due to infection.
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- KCI USA, Inc
- Responsible party
- Principal investigator, Hartzell V. Schaff, Mayo Clinic
- Investigators
- Hartzell V Schaff, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020018
- Sponsor's protocol ID
- 16-007901
- Status last verified
- Nov 2019
- First submitted
- 18 Dec 2013
- Last updated
- 6 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery
- ClinicalTrials.gov ID
- NCT02020018
- Acronym / sponsor ID
- 16-007901
- Conditions
- Surgical Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,869 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- KCI USA, Inc
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.
Detailed description
Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective group | Experimental | Device: Prevena Incision Management SystemNegative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively. |
| Retrospective arm | Active comparator | Other: Conventional sterile dry wound dressingConventional sterile dry wound dressing applied immediately postoperatively. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Transplant patients
- BMI >30
- Type I (insulin-dependent) diabetics
- Severe chronic obstructive pulmonary disease (COPD)
- Steroid-dependent patients
Key exclusion criteria (2 listed)
- BMI<30
- Thoracotomy
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 |
|---|---|---|
| Prevena Incision Management SystemAlso: negative pressure therapy, wound VAC, Prevenanegative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days | Device | Prospective group |
| Conventional sterile dry wound dressingAlso: poststernotomy wound dressing, standard dressing after sternotomyregular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy | Other | Retrospective arm |
Primary outcome
Wound Infection After Open Heart Surgery
Time frame: 30 days post-surgery
The total number of participants with surgical site infections after cardiac surgery.
1 secondary outcome
Reoperation for Wound Infection
Time frame: 30 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hartzell V Schaff, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena Incision Management System and Conventional sterile dry wound dressing in people with Surgical Wound Infection, run by Mayo Clinic at 1 site 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 6 inclusion and 2 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Infection After Open Heart Surgery (time frame: 30 days post-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 6 Nov 2019.