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Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521027
First Posted: August 27, 2007
Last Update Posted: August 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Smith & Nephew, Inc.
Information provided by:
Smith & Nephew Medical Ltd
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.

Further study details as provided by Smith & Nephew Medical Ltd:

Primary Outcome Measures:
  • Reduction in the average skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques. [ Time Frame: During surgery ]

Secondary Outcome Measures:
  • 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 ]

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
Control
Conventional surgical debridement techniques
Procedure: Conventional surgical debridement techniques
Conventional surgical debridement with scalpel and pulse lavage

Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are at least 18 years of age.
  • Males and females (provided they are not pregnant or, if of reproductive age, are using contraception).
  • Patients with a venous stasis, diabetic foot or decubitus reference ulcer located between the tibia and foot.
  • Patients undergoing surgical debridement of their reference ulcer in the operating room (OR).
  • Patients undergoing their first surgical debridement of the reference ulcer.
  • Patients suitable for debridement of their reference ulcer with both VERSAJET™ and conventional debridement techniques.
  • Patients who are able to understand the evaluation and are willing and able to provide written consent to participate in the evaluation.

Exclusion Criteria:

  • Patients with clinical signs of infection in the reference ulcer (e.g. purulence and / or odour).
  • Patients with haemophilia
  • Patients who have been treated with topical steroids, systemic immunosuppressants (including corticosteroids), anticoagulants or cytotoxic chemotherapy in the last 30 days, or who are anticipated to require such medications during the course of the study.
  • Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be infected with Human Immunodeficiency Virus (HIV).
  • Patients who suffer from acute or chronic bacterial, viral or fungal skin diseases that would interfere with wound healing.
  • Patients with a known history of poor compliance with medical treatment.
  • Patients who have participated in this evaluation previously or are currently participating in another clinical study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521027


Locations
United States, New Jersey
Clara Maass Medical Center
Belleville, New Jersey, United States, 07109
Sponsors and Collaborators
Smith & Nephew Medical Ltd
Smith & Nephew, Inc.
Investigators
Principal Investigator: Wayne J Caputo, DPM Clara Maass Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00521027     History of Changes
Other Study ID Numbers: CE025VJT
First Submitted: August 23, 2007
First Posted: August 27, 2007
Last Update Posted: August 27, 2007
Last Verified: August 2007

Keywords provided by Smith & Nephew Medical Ltd:
Debridement
hydrosurgery
Versajet
leg ulcer

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Pressure Ulcer
Varicose Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Varicose Veins