Clinical trial NCT02195310: The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
Official title: The Use of PrevenaTM Incision Management System on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Site Occurences After Sternotomy
Wound Infection
Keywords: Sternotomy
Surgical site Occurences
Negative Pressure Wound Therapy
Surgical Site Infection
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: KCI Europe Holding B.V.
name: 3M
First posted: 2014-07-21
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.
timeFrame: 30 ± 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universitat Graz
city: Salzburg
country: Austria
facility: Clinical Research Center Salzburg GmbH
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien, Universitätsklinik für Chirurgie
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Berlin
country: Germany
facility: Charité Berlin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Münster
country: Germany
facility: Westfälische Wilhelms-Universität Münster
city: Nurnberg
country: Germany
facility: Klinikum Nürnberg
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
city: Nieuwegein
country: Netherlands
facility: Stichting St. Antonius ziekenhuis
state: Utrecht
city: Rotterdam
country: Netherlands
facility: Thoraxcentrum Research BV, Erasmus University Medical Center Rotterdam
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Isala
name: Thanasie Markou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: