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

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.

Study Overview

• Status: Unknown
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: Negative Pressure Wound Therapy (NPWT); Drug: standard prophylactic therapy

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Pressure Wound Therapy (NPWT)	Device: Negative Pressure Wound Therapy (NPWT)
Active Comparator: standard prophylactic therapy	Drug: standard prophylactic therapy; administration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks	The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks	six weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 17, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 0020-14-HMO-CTIL