OsteoarthritisNCT02217202
Study of AQUACEL™ Ag Surgical Cover Dressing Following Total Knee Replacement
A study testing Aquacel Ag dressing in people with Osteoarthritis, run by Golden Jubilee National Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Aquacel Ag dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2050to Jan 2050
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Prospective Cohort Study of the AQUACEL™ Ag SURGICAL Cover Dressing in Total Knee Replacement Surgery
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.
Read the 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).
- Conditions
- Osteoarthritis
- Being tested
- Aquacel Ag dressing
- Keywords
- knee replacement, knee arthroplasty, revision, high risk
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel Ag dressingDevice
Also called Convatec Aquacel Ag dressing
Participants will have their knee arthroplasty wound dressed using the Aquacel Ag dressing instead of the standard Aquacel dressing.
| Study group | Role | What they receive |
|---|---|---|
| ConvaTec Ag | Experimental | Use of ConvaTec Ag sugical cover dressing post-operatively until wound has healed. Receives: Device: Aquacel Ag dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Up to 6 weeks post-operatively.
Secondary outcomes (1)
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?
Measured: Up to 6 weeks post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJan 2050 (estimated)
- Primary completionJan 2050 (estimated)
- Study completionJan 2050 (estimated)
Why it stopped: Funding withdrawn before ethical approval granted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- ConvaTec Inc.
- Responsible party
- Principal investigator, Dr. Alistair Ewen, Golden Jubilee National Hospital
- Investigators
- Alistair M Ewen, PhD, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217202
- Sponsor's protocol ID
- Ortho 1302
- Status last verified
- Jul 2019
- First submitted
- 12 Aug 2014
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of the AQUACEL™ Ag SURGICAL Cover Dressing in Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT02217202
- Acronym / sponsor ID
- Ortho 1302
- Conditions
- Osteoarthritis
- Keywords
- knee replacement, knee arthroplasty, revision, high risk
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn before ethical approval granted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- ConvaTec Inc.
- Study start
- Jan 2050 (estimated)
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ConvaTec Ag | Experimental | Device: Aquacel Ag dressingUse of ConvaTec Ag sugical cover dressing post-operatively until wound has healed. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- BMI ≥ 40
- Revision of total knee replacement
- Rheumatoid arthritis or secondary arthritis
- Patients on Warfarin
- Patients on steroids
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquacel Ag dressingAlso: Convatec Aquacel Ag dressingParticipants will have their knee arthroplasty wound dressed using the Aquacel Ag dressing instead of the standard Aquacel dressing. | Device | ConvaTec Ag |
Primary outcome
Incidence of surgical site infections.
Time frame: Up to 6 weeks post-operatively.
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?
1 secondary outcome
Dressing performance.
Time frame: Up to 6 weeks post-operatively.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alistair M Ewen, PhD principal investigator
Golden Jubilee National Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Aquacel Ag dressing in people with Osteoarthritis, run by Golden Jubilee National Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infections. (time frame: Up to 6 weeks post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.