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| Sponsors and Collaborators: |
Smith & Nephew Medical Ltd Smith & Nephew, Inc. |
| Information provided by: | Smith & Nephew Medical Ltd |
| ClinicalTrials.gov Identifier: | NCT00521027 |
Purpose
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.
| Condition | Intervention | Phase |
|
Diabetic Foot Varicose Ulcer Pressure Ulcer |
Device: Versajet Hydrosurgery System Procedure: Conventional surgical debridement techniques |
Phase IV |
| MedlinePlus related topics: | Diabetic Foot Foot Health Leg Injuries and Disorders Pressure Sores |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| 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. |
| Enrollment: | 46 |
| Study Start Date: | April 2006 |
| Study Completion Date: | September 2006 |
| Arms | Assigned Interventions |
|
Treatment
Debridement with Versajet Hydrosurgery system
|
Device: Versajet Hydrosurgery System
Debridement with Versajet Hydrosurgery System
|
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Control
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New Jersey | |||||
| Clara Maass Medical Center | |||||
| Belleville, New Jersey, United States, 07109 | |||||
| Smith & Nephew Medical Ltd |
| Smith & Nephew, Inc. |
| Principal Investigator: | Wayne J Caputo, DPM | Clara Maass Medical Center |
More Information
| Study ID Numbers: | CE025VJT |
| First Received: | August 23, 2007 |
| Last Updated: | August 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00521027 |
| Health Authority: | United States: Institutional Review Board |
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