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Study of AQUACEL™ Ag Surgical Cover Dressing Following Total Knee Replacement

Prospective Cohort Study of the AQUACEL™ Ag SURGICAL Cover Dressing in Total Knee Replacement Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02217202
Enrollment
0
Registered
2014-08-15
Start date
2050-01-31
Completion date
2050-01-31
Last updated
2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

knee replacement, knee arthroplasty, revision, high risk

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).

Interventions

DEVICEAquacel Ag dressing

Participants will have their knee arthroplasty wound dressed using the Aquacel Ag dressing instead of the standard Aquacel dressing.

Sponsors

ConvaTec Inc.
CollaboratorINDUSTRY
Golden Jubilee National Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of surgical site infections.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?

Secondary

MeasureTime frameDescription
Dressing performance.Up to 6 weeks post-operatively.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?

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026