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

July 29, 2019 updated by: Dr. Alistair Ewen, Golden Jubilee National Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ConvaTec Ag
Use of ConvaTec Ag sugical cover dressing post-operatively until wound has healed.
Device: Aquacel Ag dressing
Participants will have their knee arthroplasty wound dressed using the Aquacel Ag dressing instead of the standard Aquacel dressing.
Other Names:
  • Convatec Aquacel Ag dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
Up to 6 weeks post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dressing performance.
Time Frame: 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?
Up to 6 weeks post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golden Jubilee National Hospital

Collaborators

ConvaTec Inc.

Investigators

  • Principal Investigator: Alistair M Ewen, PhD, Golden Jubilee National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2050

Primary Completion (Anticipated)

January 1, 2050

Study Completion (Anticipated)

January 1, 2050

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ortho 1302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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