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

NCT02195310 | Terminated Results

• 1 other identifier: KCI.2013.Prevena.01
• Study Type: interventional
• Target: 342
• Locations: 3 countries
• Sites: 13

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.

Conditions

Surgical Site Occurences After Sternotomy; Wound Infection

Keywords

Sternotomy; Surgical site Occurences; Negative Pressure Wound Therapy; Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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).

Device: Conventional sterile wound dressings

Interventions

Prevena™ Incision Management System DEVICE

Prevena™ Incision Management System is used after sternotomy on the closed incision

Also known as: Prevena Peel & Place

Prevena™ Incision Management System

Conventional sterile wound dressings DEVICE

Conventional sterile wound dressings are placed after sternotomy on the closed incision

Conventional sterile wound dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Solventum US LLC: lead
• KCI Europe Holding B.V.: collaborator
• 3M: collaborator

Study Sites (13)

Medizinische Universitat Graz

Graz, 8036, Austria

Location

Clinical Research Center Salzburg GmbH

Salzburg, 5020, Austria

Location

Medizinische Universitaet Wien, Universitätsklinik für Chirurgie

Vienna, A-1090, Austria

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Charité Berlin

Berlin, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Westfälische Wilhelms-Universität Münster

Münster, 48149, Germany

Location

Klinikum Nürnberg

Nuremberg, 90471, Germany

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Isala Klinieken

Zwolle, Overijssel, 8000 GK, Netherlands

Location

Thoraxcentrum Research BV, Erasmus University Medical Center Rotterdam

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Stichting St. Antonius ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Wound Infection; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Inclusion criteria were broad, expected event rates in the control group proved to be incorrect. Acelity plans to continue studying those at high risk for postoperative wound complications (e.g BMI\>35).

Results Point of Contact

• Title: Daniela Weichert, PhD
• Organization: KCI Europe Holding B.V.

daniela.weichert@acelity.com

+353 (0) 860436155

Study Officials

• Thanasie Markou, MD, PhD

  Isala

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 21, 2014
• Study Start: November 12, 2013
• Primary Completion: August 15, 2016
• Study Completion: October 17, 2016
• Last Updated: October 2, 2024
• Results First Posted: August 5, 2019

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); DE (5); NL (5)