Evaluating The Use of Silver-coated Segmental Limb-Salvage Implants on the Risk of Surgical Site Infection: A Multi-centre Prospective Randomized Controlled Trial. - Trial ANZCTR12623000769684

Timeline & Enrollment

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