Trials / Unknown
UnknownNCT02118558
Negative Pressure Wound Therapy -PREVENA in Prevention of Infections After Total Knee Arthroplasty (TKA)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Hadassah Medical Organization · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2016-01-01
- Completion
- 2017-01-01
- First posted
- 2014-04-21
- Last updated
- 2014-04-21
Source: ClinicalTrials.gov record NCT02118558. Inclusion in this directory is not an endorsement.