Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Experimental |
| |
| standard prophylactic therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Device |
| ||
| standard prophylactic therapy |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
administration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing |
|
The number of patients recommended to undergo further procedural intervention because of the infection. |
| 12 MONTHS |