NCT01854138

Brief Summary

Determine the extent to which application of the Prevena vacuum system to clean surgical incisions immediately following surgical procedure (total hip or total knee arthroplasty) will reduce the rates of:

  • readmission to hospital for surgical intervention due to wound complications
  • seroma
  • hematoma
  • infection compared to group of patients whose wounds were covered with traditional gauze dressings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 12, 2018

Completed
Last Updated

July 12, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

May 12, 2013

Results QC Date

April 4, 2018

Last Update Submit

June 11, 2018

Conditions

Infection of Total Hip Joint Prosthesis

Keywords

primary knee arthroplastyprimary hip arthroplastynegative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Hospital Readmissions

    60 days

Secondary Outcomes (3)

  • Number of Participants With Infection

    60 days

  • Number of Participants With Seroma

    60 days

  • Number of Participants With Hematoma

    60 days

Study Arms (2)

Control

NO INTERVENTION

Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

Prevena Knee/Hip

EXPERIMENTAL

Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound.

Device: Prevena Incision Management System

Interventions

Prevena Incision Management SystemDEVICE

Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.

Also known as: negative pressure wound therapy
Prevena Knee/Hip

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing primary total hip or knee arthroplasty
  • years of age

You may not qualify if:

  • Patients undergoing revision total hip or knee arthroplasty
  • Allergy to silver
  • Current systemic infection
  • Currently being treated for malignancy
  • Patients suffering from anemia or malnutrition
  • Patients afflicted with jaundice
  • Patients deemed to be non-compliant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wildwood Orthopaedic and Spine Hospital

Toledo, Ohio, 43615, United States

Location

Related Publications (1)

  • Redfern RE, Cameron-Ruetz C, O'Drobinak SK, Chen JT, Beer KJ. Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3333-3339. doi: 10.1016/j.arth.2017.06.019. Epub 2017 Jun 17.

    PMID: 28705547DERIVED

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Results Point of Contact

Title
Karl J. Beer, MD
Organization
ProMedica
karl.beer@promedica.org
419-578-4260

Study Officials

  • Karl Beer, MD

    ProMedica Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 12, 2013

First Posted

May 15, 2013

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

July 12, 2018

Results First Posted

July 12, 2018

Record last verified: 2018-06

Locations

US(1)