Surgical Site Occurences After SternotomyNCT02195310
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
A study testing Prevena™ Incision Management System and Conventional sterile wound dressings in people with Surgical Site Occurences After Sternotomy and Wound Infection, run by Solventum US LLC at 13 sites in 3 countries.
Trial summary
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Occurences After Sternotomy, Wound Infection
- What is being tested?
- Prevena™ Incision Management System and Conventional sterile wound dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 12 Nov 2013to 17 Oct 2016
- Phase
- Interventional
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
- Is male or female and 18 years of age or older
- Is scheduled for elective cardiac surgery for which a median sternotomy is needed (including coronary artery bypass grafting (CABG), valvular repair or replacement with or without CABG). Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure.
- Is capable of providing informed consent, which must be obtained prior to any study-related procedures
- Is willing and able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Is pregnant
- The use of Prevena post surgery is contra indicated per investigator's discretion
- Has a systemic infection at the time of surgery: systemic infection is diagnosed on the basis of clinical signs of sepsis with or without a positive culture of an organism from the bloodstream
- Has a remote body site infection at the time of surgery (including dental, urinary or skin soft tissue infections)
- Is known to have a current nasal swab positive for methicillin-resistant staphylococcus aureus (MRSA)
- Has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
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- Has a requirement for competing wound therapy and procedures.
- Any concomitant therapies (including other NPWT treatment) or procedures deviating from the clinical standard incision treatment or with investigational device at the location of the sternotomy (e.g. use of NPWT at other location of the body is allowed)
- Any other therapies or procedures that, in the opinion of the treating physician, would affect or influence postoperative wound stability or healing
- Is simultaneously participating in another interventional trial
- Requires use of liquid skin adhesives or glues during skin closure
- Is known to be serology positive for hepatitis B, hepatitis C or HIV
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Germany5 sites
Deutsches Herzzentrum Berlin
Berlin, 13353
Charité Berlin
Berlin
Universitätsklinikum Erlangen
Erlangen, 91054
Westfälische Wilhelms-Universität Münster
Münster, 48149
Klinikum Nürnberg
Nuremberg, 90471
Netherlands5 sites
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
University Medical Center Groningen
Groningen, 9713 GZ
Stichting St. Antonius ziekenhuis
Nieuwegein, Utrecht, 3435 CM
Thoraxcentrum Research BV, Erasmus University Medical Center Rotterdam
Rotterdam, South Holland, 3015 GD
Isala Klinieken
Zwolle, Overijssel, 8000 GK
Austria3 sites
Medizinische Universitat Graz
Graz, 8036
Clinical Research Center Salzburg GmbH
Salzburg, 5020
Medizinische Universitaet Wien, Universitätsklinik für Chirurgie
Vienna, A-1090
About this study
Official title: The Use of PrevenaTM Incision Management System on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.
The study is conducted in The Netherlands, Germany and Austria.
Read the detailed description
The Prevena™ IMS is intended to manage the environment of closed surgically incision and surrounding intact skin for patients with an increased risk for developing post-operative complications such as infection.The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.
The Prevena™ IMS is a small portable device, which consists of a mild vacuum unit that delivers negative pressure and a dressing that is intended for use over closed incisions after surgery. It is used for a minimum of 4 days up to a maximum of 7 days. This system is commercially available and has a CE mark, which means that it is approved for the use on the European market. It is intended to be applied immediately post sternotomy surgery on a closed clean incision.
The results of this study could contribute to a better and faster healing of the incision.
The study is conducted in The Netherlands, Germany and Austria.
- Being tested
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Keywords
- Sternotomy, Surgical site Occurences, Negative Pressure Wound Therapy, Surgical Site Infection
- Medical subject headings
- Wound Infection, 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 Prevena Peel & Place
Prevena™ Incision Management System is used after sternotomy on the closed incision
Conventional sterile wound dressingsDevice
Conventional sterile wound dressings are placed after sternotomy on the closed incision
| Study group | Role | What they receive |
|---|---|---|
| Prevena™ Incision Management System | Experimental | Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use Receives: Device: Prevena™ Incision Management System |
| Conventional sterile wound dressings | Active comparator | Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze). Receives: Device: Conventional sterile wound dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.
The SSI rate (in %) was calculated for each treatment arm as follows:
SSI rate = [Number of Subjects who experienced SSI] / [Number of Subjects Analyzed] * 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event
Measured: 30 ± 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study start12 Nov 2013
- Primary completion15 Aug 2016
- Study completion17 Oct 2016
Why it stopped: due to futility
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 Site Occurences After SternotomyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCI Europe Holding B.V., 3M
- Responsible party
- Sponsor
- Investigators
- Thanasie Markou, MD, PhD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195310
- Sponsor's protocol ID
- KCI.2013.Prevena.01
- Status last verified
- Sep 2024
- First submitted
- 16 Jul 2014
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No