The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.

Solventum US LLC

Status: Terminated

Conditions: Surgical Site Occurences After Sternotomy; Wound Infection

Treatments: Device: Prevena™ Incision Management System; Device: Conventional sterile wound dressings

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195310

KCI.2013.Prevena.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 342 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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342 participants in 2 patient groups

Prevena™ Incision Management System

Experimental group

Description:

Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use

Treatment:

Device: Prevena™ Incision Management System

Conventional sterile wound dressings

Active Comparator group

Description:

Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).

Treatment:

Device: Conventional sterile wound dressings