Plastic surgery is a small surgical specialty covering hand surgery, trauma, congenital defects, burns and cancer. Plastic surgeons work with all other surgical specialties to undertake complex reconstructions and save lives.
The clinical research evidence for plastic surgery is based on poorly conducted clinical research with only 3% of the published work classified as randomised controlled trials (RCTs). It is recognised that large scale research undertaken in multiple centers, known as multicenter randomised controlled trials, generate the highest level of evidence on which to base best practice. Yet in plastic surgery it is estimated that only 2-3 multi-center RCT's are published globally a year.
Plastic and hand surgery are poorly represented on the clinical research landscape with virtually no clinical trials or patients recruited to the NIHR portfolio. The reason for such poor clinical evidence is multifactorial, but stems from a lack of a defined pathway that practicing plastic surgeons can access to rigorously test the interventions they perform.
In order to address this the Royal College of Surgeons (RCS) launched a clinical trials initiative in 2012. They appointed 5 Surgical Trials Centers, of which Oxford was one, with the remit to increase both the number and quality of clinical trials in surgery. In order to help these trials units, Surgical Specialty Leads (SSL) were appointed nationally to develop trails within their specialties.
This initiative has been embraced by the plastic and hand surgery community and provides a mechanism to allow plastic and hand surgeons to directly access the expertise needed to undertake high quality clinical research with direct benefit to patient care. It has allowed us to develop a culture of clinical trials within Plastic Surgery and its sub-specialty, Hand Surgery, within the space of just 2 years.
Professor Jain took up the role of RCS SSL in 2013 representing both the BSSH and BAPRAS and he has had a tremendous response from both associations, with over 330 members of the Reconstructive Surgery Trials Network (RSTN), which I set up to deliver clinical research for the BSSH and BAPRAS under the banner of the RCS initiative. We have over 60 units involved providing us with representation across England, Wales, Scotland and Northern Ireland; we even have members in Italy, Australia and the USA. We are supported by SITU at Oxford.
We have annually run very successful trials days at the Royal College of Surgeons in which 250 surgeons have been taught on trials related topics, trained in GCP and have had the opportunity to present their trial ideas. We have also established a regular trials session at the national winter BAPRAS meeting annually.
Our first trial (NINJA - nail bed injuries) is adopted onto the NIHR portfolio and the pilot has recruited from 4 centers. A collaborative trial with the Association of Breast Surgeons has been awarded RfPB funding from the NIHR and plastic surgeons have recruited a third of the patients in total so far. There are 5 other trials at various stages of development. There are also 2 large multicenter audit projects running nationally. Plastic surgeons are also collaborating with other specialties on various projects.