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Trial of Versajet Compared With Conventional Treatment in Acute and Chronic Wounds

NCT01050673 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-12

Study results available
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Summary

It is increasingly recognised that the debridement of devitalised, bacterially contaminated or senescent tissue is an essential component of the effective treatment of delayed healing wounds.

Whilst surgical debridement procedures have conventionally been performed with scalpels and other sharp instrumentation, alternative techniques such as the VERSAJET Hydrosurgery System are becoming more widespread.

To increase the adoption of this new technology, it is essential that clinical improvements are assessed alongside the potential impact on the costs of debridement and the net financial impact on the hospital.

It is hypothesised that a decrease in the time to achieve stable wound closure will not only lead to a patient benefit, but also a potential reduction in the cost of treatment due to e.g. repeat procedures, longer hospital stay, infection etc. The purpose of this study is to investigate the difference in time to closure of wounds surgically excised with VERSAJET Hydrosurgery System and those surgically excised using conventional operating room techniques.

Conditions

  • Surgical Wound Dehiscence

Interventions

DEVICE

VERSAJET

Hydro-surgery debridement

PROCEDURE

Scalpel or blade

Conventional Surgical Debridement

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert D Galiano, MD · Northwestern University Feinberg School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01050673 on ClinicalTrials.gov