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

February 14, 2018 updated by: Smith & Nephew, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Clara Maass Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment
Debridement with Versajet Hydrosurgery system
Device: Versajet Hydrosurgery System
Debridement with Versajet Hydrosurgery System
Other: Control
Conventional surgical debridement techniques
Procedure: Conventional surgical debridement techniques
Conventional surgical debridement with scalpel and pulse lavage

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
3 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Wayne J Caputo, DPM, Clara Maass Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 23, 2007

First Submitted That Met QC Criteria

August 23, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE025VJT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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