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

NCT00521027 | Completed Phase 4

• 1 other identifier: CE025VJT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer

Keywords

Debridement; hydrosurgery; Versajet; leg ulcer

Outcome Measures

Primary Outcomes (1)

• Reduction in the average skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques.

  During surgery

Secondary Outcomes (2)

• Difference in the total average time of the debridement procedure, including preparation, skin-to-skin and recovery, according to the debridement technique.

  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

  3 months post-op

Study Arms (2)

Treatment

OTHER

Debridement with Versajet Hydrosurgery system

Device: Versajet Hydrosurgery System

Control

OTHER

Conventional surgical debridement techniques

Procedure: Conventional surgical debridement techniques

Interventions

Versajet Hydrosurgery System DEVICE

Debridement with Versajet Hydrosurgery System

Treatment

Conventional surgical debridement techniques PROCEDURE

Conventional surgical debridement with scalpel and pulse lavage

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

Clara Maass Medical Center

Belleville, New Jersey, 07109, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Wayne J Caputo, DPM

  Clara Maass Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 27, 2007
• Study Start: April 1, 2006
• Study Completion: September 1, 2006
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (1)