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

Total Knee Replacement Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02118558
• Other study ID #: 0020-14-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 16, 2014
• Last updated: April 17, 2014
• Start date: June 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2014
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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