Osteoarthritis Clinical Trial
Official title:
Prospective Cohort Study of the AQUACEL™ Ag SURGICAL Cover Dressing in Total Knee Replacement Surgery
NCT number | NCT02217202 |
Other study ID # | Ortho 1302 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2050 |
Est. completion date | January 2050 |
Verified date | July 2019 |
Source | Golden Jubilee National Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to determine whether the AQUACEL™ Ag SURGICAL cover dressing is successful in reducing the incidence of wound infection in high risk patients following total knee replacement. We will also look at the status of the wound, occurrence of blistering, biochemistry results, dressing wear time and the number of dressing changes to quantify the dressing performance.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2050 |
Est. primary completion date | January 2050 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - BMI = 40 - Revision of total knee replacement - Rheumatoid arthritis or secondary arthritis - Patients on Warfarin - Patients on steroids - Patients on long term antibiotics - Previous deep joint infection Exclusion Criteria: - Allergy to silver - Simultaneous bilateral total knee replacement patients - Patients who do not wish to participate - Patients who are unable to give informed consent - Patients who are unable to attend Golden Jubilee National Hospital for follow up |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Golden Jubilee National Hospital | ConvaTec Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of surgical site infections. | What is the incidence of surgical site infections following total knee replacements and revisions in high risk patients when using the AQUACEL™ Ag SURGICAL cover dressing? | Up to 6 weeks post-operatively. | |
Secondary | Dressing performance. | How does the AQUACEL™ Ag SURGICAL cover dressing perform in terms of the occurrence of blistering, dressing wear time and the number of dressing changes, ease of use and number of unforeseen complications? | Up to 6 weeks post-operatively. |
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