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

Phase 2

• Conditions: Total Knee Replacement
• Interventions: Device: Negative Pressure Wound Therapy (NPWT); Drug: standard prophylactic therapy

• Registration Number: NCT02118558
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-17
• Last Update Submitted: 2014-04-17
• Study First Posted: 2014-04-21
• Last Update Posted: 2014-04-21
• Study Start: 2014-06
• Primary Completion: 2016-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Ages: 18 to 80
• Males- not involved in active military duty.
• Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.

Exclusion Criteria

• Active systemic or local infection.
• History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
• Active autoimmune disease.
• Any past or present immunosuppressive treatment.
• Current treatment with chemotherapeutic agents
• History of metabolic bone disease (primary or secondary).
• Chronic renal insufficiency (defined by 50% increase of normal levels).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy (NPWT)	Negative Pressure Wound Therapy (NPWT)	-
standard prophylactic therapy	standard prophylactic therapy	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks	six weeks	The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks

Secondary Outcome Measures

Name	Time	Method
1. To assess the proportion on infections at two weeks and 6 weeks of follow-up.	two weeks and six weeks	To assess the proportion on infections at two weeks and 6 weeks of follow-up.
The number of patients recommended to undergo further procedural intervention because of the infection.	12 MONTHS	The number of patients recommended to undergo further procedural intervention because of the infection.