NCT02127281

Brief Summary

The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk patients prevents wound complications and decreases reoperation rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

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

April 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 26, 2018

Completed
Last Updated

September 19, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

April 29, 2014

Results QC Date

August 17, 2017

Last Update Submit

August 21, 2018

Conditions

Prosthesis-related InfectionsWound ComplicationsJoint DiseasesMusculoskeletal Diseases

Keywords

Revision total knee arthroplastyRevision total hip arthroplastyNegative pressure wound therapy system (NPWT)Drainage

Outcome Measures

Primary Outcomes (3)

  • Number of Patients With Wound Complications

    Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.

    Within 90 days after surgery

  • Re-operation Rates

    Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision

    Within 90 days after surgery

  • Readmission Rates

    Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision

    Within 90 days after surgery

Secondary Outcomes (7)

  • Knee Flexion

    4 weeks postoperative

  • HOOS and KOOS Scores at 90 Days Postoperatively

    90 days postoperative

  • Timed-up-and-go Test

    4 weeks postoperatively

  • Hip Range of Motion (Flexion)

    4 weeks postoperative

  • VR-12 Questionnaire

    90 days postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Prevena

ACTIVE COMPARATOR

Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).

Device: Prevena

Control

NO INTERVENTION

A standard of care sterile wound dressing will be placed.

Interventions

PrevenaDEVICE

Device will be applied at end of procedure over closed incision.

Prevena

Eligibility Criteria

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

You may qualify if:

  • Scheduled revision Total Hip or Knee Arthroplasty Procedure
  • Presence of one of the following: body mass index (BMI) greater than 35, use of blood thinners other than acetylsalicylic acid (ASA) after surgery, peripheral vascular disease, depression, diabetes mellitus, current tobacco use, history of prior infection, current use of immunomodulators or steroids, current history of cancer or hematological malignancy, rheumatoid arthritis, renal failure or dialysis, malnutrition, liver disease, transplant status, or HIV.

You may not qualify if:

  • Patient lives \>100 miles from hospital
  • Patient is \< 18 years old
  • Silver allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 440195, United States

Location

Related Publications (2)

  • Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3.

    PMID: 23539123BACKGROUND

  • Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25.

    PMID: 19554385BACKGROUND

MeSH Terms

Conditions

Prosthesis-Related InfectionsJoint DiseasesMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Alison K. Klika, MS, Research Manager, Department of Orthopaedic Surgery
Organization
Cleveland Clinic
klikaa@ccf.org
(216) 444-4954

Study Officials

  • Carlos Higuera-Rueda, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff, Adult Reconstruction

Study Record Dates

First Submitted

April 29, 2014

First Posted

April 30, 2014

Study Start

May 1, 2014

Primary Completion

April 24, 2017

Study Completion

June 30, 2017

Last Updated

September 19, 2018

Results First Posted

March 26, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)