N/A
N=648
Evaluating Advantages of Prevena After Hip and Knee Arthroplasty
Infection of Total Hip Joint Prosthesis
Bottom Line
View on ClinicalTrials.gov: NCT01854138 ↗Enrolled (actual)
648
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Hospital Readmissions — 15; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prevena Incision Management System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ProMedica Health System
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hospital Readmissions |
15; 3 | — |
| SECONDARY Number of Participants With Infection |
14; 2 | — |
| SECONDARY Number of Participants With Seroma |
2; 0 | — |
| SECONDARY Number of Participants With Hematoma |
9; 0 | — |
Summary
Determine the extent to which application of the Prevena vacuum system to clean surgical incisions immediately following surgical procedure (total hip or total knee arthroplasty) will reduce the rates of:
* readmission to hospital for surgical intervention due to wound complications
* seroma
* hematoma
* infection compared to group of patients whose wounds were covered with traditional gauze dressings.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing primary total hip or knee arthroplasty
- 18-85 years of age
Exclusion Criteria
- Patients undergoing revision total hip or knee arthroplasty
- Allergy to silver
- Current systemic infection
- Currently being treated for malignancy
- Patients suffering from anemia or malnutrition
- Patients afflicted with jaundice
- Patients deemed to be non-compliant
Data sourced from ClinicalTrials.gov (NCT01854138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.