Study of AQUACEL™ Ag Surgical Cover Dressing Following Total Knee Replacement
Primary Purpose
Osteoarthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aquacel Ag dressing
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoarthritis focused on measuring knee replacement, knee arthroplasty, revision, high risk
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ConvaTec Ag
Arm Description
Use of ConvaTec Ag sugical cover dressing post-operatively until wound has healed.
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
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?
Full Information
NCT ID
NCT02217202
First Posted
August 12, 2014
Last Updated
July 29, 2019
Sponsor
Golden Jubilee National Hospital
Collaborators
ConvaTec Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02217202
Brief Title
Study of AQUACEL™ Ag Surgical Cover Dressing Following Total Knee Replacement
Official Title
Prospective Cohort Study of the AQUACEL™ Ag SURGICAL Cover Dressing in Total Knee Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Funding withdrawn before ethical approval granted
Study Start Date
January 2050 (Anticipated)
Primary Completion Date
January 2050 (Anticipated)
Study Completion Date
January 2050 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Golden Jubilee National Hospital
Collaborators
ConvaTec Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
All eligible patients over a two month period will be identified and invited to take part in the study. Identification will be done though examination of clinical case notes of patients who are candidates for total knee replacement or revision surgery. Demographic and medical history data for all study patients will be collected. This will include age, gender, BMI, smoking habits, alcohol consumption, diagnosis, operation, laterality and comorbidities. All eligible patients who fulfil the selection criteria will be informed of the study at their pre-surgery consultation, provided with the patient information sheet and approached to take part in the study at a later date.
Patients who have agreed to take part in the study will have their knee surgery performed in the same manner as if they had not agreed to take part. The clinical team will be informed of a patient's participation in the study and will ensure that the AQUACEL™ Ag SURGICAL cover dressing is used instead of the standard dressing protocol with these patients, both immediately after surgery and at any other time when the patient requires the dressing to be changed before discharge. Study patients will also be given a sufficient supply of the dressing for home use on discharge from the hospital.
Patients will be observed during their inpatient stay where data including the wound status, occurrence of blistering, dressing wear time, number of dressing changes, ease of dressing changes, any unforeseen side effects and any surgical site infection will be recorded to quantify the dressing performance by the healthcare staff. Appropriate data from lab results will be extracted. After discharge, data will be collected from the Prevention and Control of Infection team at regular intervals up to 30 days postoperatively. Study patients will be followed up, as per hospital protocol, at six weeks by the Arthroplasty Outcomes team. Data from this follow up will also be included in the study. After this appointment, patients will no longer have any involvement in the study.
Once the data set is completed statistical analysis will be carried out to compare the results of this study with those of a retrospective cohort study of a similar patient group, where the Jubilee method dressing (a combination of DuoDERM® and AQUACEL® was used).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
knee replacement, knee arthroplasty, revision, high risk
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ConvaTec Ag
Arm Type
Experimental
Arm Description
Use of ConvaTec Ag sugical cover dressing post-operatively until wound has healed.
Intervention Type
Device
Intervention Name(s)
Aquacel Ag dressing
Other Intervention Name(s)
Convatec Aquacel Ag dressing
Intervention Description
Participants will have their knee arthroplasty wound dressed using the Aquacel Ag dressing instead of the standard Aquacel dressing.
Primary Outcome Measure Information:
Title
Incidence of surgical site infections.
Description
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?
Time Frame
Up to 6 weeks post-operatively.
Secondary Outcome Measure Information:
Title
Dressing performance.
Description
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?
Time Frame
Up to 6 weeks post-operatively.
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alistair M Ewen, PhD
Organizational Affiliation
Golden Jubilee National Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of AQUACEL™ Ag Surgical Cover Dressing Following Total Knee Replacement
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