Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
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.
|Diabetic Foot Varicose Ulcer Pressure Ulcer||Device: Versajet Hydrosurgery System Procedure: Conventional surgical debridement techniques||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Reduction in the average skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques. [ Time Frame: During surgery ]
- Difference in the total average time of the debridement procedure, including preparation, skin-to-skin and recovery, according to the debridement technique. [ Time Frame: Entry into OR holding area to discharge from recovery room ]
- Difference in outcomes of the procedure, according to the debridement technique in terms of; time to wound closure, number of subsequent debridements, number of serious adverse events [ Time Frame: 3 months post-op ]
|Study Start Date:||April 2006|
|Study Completion Date:||September 2006|
Debridement with Versajet Hydrosurgery system
Device: Versajet Hydrosurgery System
Debridement with Versajet Hydrosurgery System
Conventional surgical debridement techniques
Procedure: Conventional surgical debridement techniques
Conventional surgical debridement with scalpel and pulse lavage
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521027
|United States, New Jersey|
|Clara Maass Medical Center|
|Belleville, New Jersey, United States, 07109|
|Principal Investigator:||Wayne J Caputo, DPM||Clara Maass Medical Center|