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

NCT02118558 | Unknown Phase 2

• 1 other identifier: 0020-14-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 1. 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.

  12 MONTHS

Study Arms (2)

Negative Pressure Wound Therapy (NPWT)

EXPERIMENTAL

Device: Negative Pressure Wound Therapy (NPWT)

standard prophylactic therapy

ACTIVE COMPARATOR

Drug: standard prophylactic therapy

Interventions

Negative Pressure Wound Therapy (NPWT) DEVICE

Negative Pressure Wound Therapy (NPWT)

standard prophylactic therapy DRUG

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

standard prophylactic therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 21, 2014

Record last verified: 2014-04