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Negative Pressure Wound Therapy -PREVENA in Prevention of Infections After Total Knee Arthroplasty (TKA)

NCT02118558 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-04-21

No results posted yet for this study

Summary

This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will be randomized to the treatment group and undergo the study intervention - (NPWT) The intervention will take place at the end of the surgery. The Patients that are randomized to the control group will receive standard treatment. Both groups will be assessed at two weeks and six weeks. period.

Conditions

  • Total Knee Replacement

Interventions

DEVICE

Negative Pressure Wound Therapy (NPWT)

DRUG

standard prophylactic therapy

administration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-01-31
Completion
2017-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02118558 on ClinicalTrials.gov