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

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.

Study Overview

• Status: Terminated
• Conditions: Wound Infection; Surgical Site Occurences After Sternotomy
• Intervention / Treatment: Device: Prevena™ Incision Management System; Device: Conventional sterile wound dressings

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.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz
  • Salzburg, Austria, 5020
    • Clinical Research Center Salzburg GmbH
  • Vienna, Austria, A-1090
    • Medizinische Universitaet Wien, Universitätsklinik für Chirurgie
• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Berlin, Germany
    • Charite Berlin
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Münster, Germany, 48149
    • Westfälische Wilhelms-Universität Münster
  • Nurnberg, Germany, 90471
    • Klinikum Nürnberg
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Ziekenhuis Eindhoven
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8000 GK
      • Isala Klinieken
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • Stichting St. Antonius ziekenhuis
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Thoraxcentrum Research BV, Erasmus University Medical Center Rotterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevena™ Incision Management System; Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use	Device: Prevena™ Incision Management System; Prevena™ Incision Management System is used after sternotomy on the closed incision; Other Names: Prevena Peel & Place
Active Comparator: Conventional sterile wound dressings; Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).	Device: Conventional sterile wound dressings; Conventional sterile wound dressings are placed after sternotomy on the closed incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 ± 4 days

Collaborators and Investigators

• Sponsor: 3M
• Collaborators: KCI Europe Holding B.V.
• Investigators: Principal Investigator: Thanasie Markou, MD, PhD, Isala

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2013
• Primary Completion (Actual): August 15, 2016
• Study Completion (Actual): October 17, 2016

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Sternotomy; Negative Pressure Wound Therapy; Surgical site Occurences
• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: KCI.2013.Prevena.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO