Back to resultsStudy Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
Primary Purpose
Diabetic Foot, Varicose Ulcer, Pressure Ulcer
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Versajet Hydrosurgery System
Conventional surgical debridement techniques
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Debridement, hydrosurgery, Versajet, leg ulcer
Eligibility 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.
Sites / Locations
- Clara Maass Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Treatment
Control
Arm Description
Debridement with Versajet Hydrosurgery system
Conventional surgical debridement techniques
Outcomes
Primary Outcome Measures
Reduction in the average skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques.
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.
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
Full Information
NCT ID
NCT00521027
First Posted
August 23, 2007
Last Updated
February 14, 2018
Sponsor
Smith & Nephew, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00521027
Brief Title
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Varicose Ulcer, Pressure Ulcer
Keywords
Debridement, hydrosurgery, Versajet, leg ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
Debridement with Versajet Hydrosurgery system
Arm Title
Control
Arm Type
Other
Arm Description
Conventional surgical debridement techniques
Intervention Type
Device
Intervention Name(s)
Versajet Hydrosurgery System
Intervention Description
Debridement with Versajet Hydrosurgery System
Intervention Type
Procedure
Intervention Name(s)
Conventional surgical debridement techniques
Intervention Description
Conventional surgical debridement with scalpel and pulse lavage
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne J Caputo, DPM
Organizational Affiliation
Clara Maass Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clara Maass Medical Center
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
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