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ANZCTR12623000769684Not yet recruiting

Evaluating The Use of Silver-coated Segmental Limb-Salvage Implants on the Risk of Surgical Site Infection: A Multi-centre Prospective Randomized Controlled Trial.

Evaluating The Use of Silver-coated Segmental Limb-Salvage Implants on the Risk of Surgical Site Infection in Adults Undergoing Segmental Bone Reconstruction of the Distal Femur: A Multi-centre Prospective Randomized Controlled Trial.
Life HealthcareNot ApplicableAustralian New Zealand Clinical Trials RegistrydeviceDevice trial
VerifiedAustralian New Zealand Clinical Trials Registry
Study focus
Disease/Condition
Infection
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Life Healthcare
Location
Australia
Timeline & enrollment
Phase
Not Applicable
Start date
Dec 01, 2023
End date
Jun 28, 2024
Primary outcome

The primary outcome of this study is to assess surgical site infection (SSI) prospectively by qualified medical or nursing staff, with the presence or absence of infection recorded at 2, 5, 14, 42 days, 6 months, 1 year and 2 years postoperatively.

Summary

This trial is exploring the efficacy of coating limb implants with a galvanised silver layer for the prevention of surgical site infection. Who is it for? You may be eligible for this study if you are an adult who has undergone resection of primary or secondary musculoskeletal malignancy, and require subsequent segmental bone reconstruction of the distal femur. In addition, there will be other participant groups recruited including those requiring reconstruction following trauma or implant failure. Study details Participants will be randomly allocated to receive implants with or without a galvanised silver coating. The surgery will be performed by an orthopaedic surgeon. Participants will be asked to attend follow-up appointments for up to 2 years after the surgery to establish whether any surgical site infection or other complications have occurred. It is hoped that information from this study will establish the utility of silver-coating limb salvage implants in reducing the risk of surgical site infection

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsInfection following immunizationOther infectious diseasesViral infection, unspecified
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12623000769684
Type
Device Trial
About this record

Access comprehensive clinical trial information for ANZCTR12623000769684 through Pure Global AI's free database. This Not Applicable trial is sponsored by Life Healthcare and is currently Not yet recruiting. The study focuses on Infection.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Australian New Zealand Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.