CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
VERSAJET +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01050673
NCT01050673N/ACompleted

A Study to Investigate the Time to Closure of Delayed Healing Dehisced Incisions, Delayed Healing Traumatic Wounds or Chronic Cutaneous Defects Surgically Excised With VERSAJET Compared Conventional Operating Room Techniques

Smith & Nephew, Inc.·interventional·Posted Jan 15, 2010·Updated Mar 12, 2018

In Brief

A clinical study evaluating VERSAJET and Scalpel or blade for Surgical Wound Dehiscence. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2010
Enrollment StartNov 1, 2007
Primary CompletionJun 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.5 years ago

Interventions

VERSAJETdevice

Hydro-surgery debridement

Scalpel or bladeprocedure

Conventional Surgical Debridement