NCT02217202

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
0mo left

Started Jan 2050

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
35.4 years until next milestone

Study Start

First participant enrolled

January 1, 2050

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2050

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2050

Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

August 12, 2014

Last Update Submit

July 29, 2019

Conditions

Osteoarthritis

Keywords

knee replacementknee arthroplastyrevisionhigh risk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Dressing performance.

    Up to 6 weeks post-operatively.

Study Arms (1)

ConvaTec Ag

EXPERIMENTAL

Use of ConvaTec Ag sugical cover dressing post-operatively until wound has healed.

Device: Aquacel Ag dressing

Interventions

Aquacel Ag dressingDEVICE

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

Also known as: Convatec Aquacel Ag dressing
ConvaTec Ag

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Alistair M Ewen, PhD

    Golden Jubilee National Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Researcher

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start (Estimated)

January 1, 2050

Primary Completion (Estimated)

January 1, 2050

Study Completion (Estimated)

January 1, 2050

Last Updated

July 31, 2019

Record last verified: 2019-07