Diabetic Foot Clinical Trial
Official title:
A Prospective, Comparative, Single-centre Clinical Evaluation to Investigate the Skin-to-skin Time of the First Surgical Debridement of Lower Extremity Ulcers With VERSAJET™ Hydrosurgery System and Conventional Debridement Techniques.
The purpose of this study is to compare the VERSAJET™ device with conventional surgical
procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of
lower limb ulcers.
It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the
VERSAJET™ device than with conventional surgical procedures.
This is prospective, comparative clinical evaluation to investigate whether there is a
reduction in the skin-to-skin time of the first surgical debridement with VERSAJET™, compared
to conventional debridement techniques. Skin-to-skin time is defined as the time of incision
to the end time of debridement (wound ready for dressing application). Conventional
debridement is defined as scalpel plus pulse lavage.
The purpose of this comparison is to demonstrate the resource savings which VERSAJET™ may
provide in terms of operating room (OR) and personnel time, in addition to the potential to
reduce the procedure, and possibly anaesthetic, time for the patient. It is envisaged that
this information, combined with the costs associated with the procedure, will also provide
valuable economic data to help justify the use of VERSAJET™ from a financial perspective and
support the future commercial success of the device.
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