CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Standard Wound Dressing +1 moreprocedure
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/NCT00582361
NCT00582361N/ACompleted
CompareCT.gov

Vacuum Assisted Closure as a Treatment for Open Fractures

University of Alabama at Birmingham·interventional·Posted Dec 28, 2007·Updated Aug 14, 2013

In Brief

A clinical study evaluating Standard Wound Dressing and VAC for Orthopaedic Traumatic Open Fractures. Completed, enrolled 63 participants across 1 site.

Detailed Summary

This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating traumatic wounds sustained associated with an open fracture.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrthopaedic Traumatic Open Fractures
CountriesUnited States
CollaboratorsKCI USA, Inc

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2007
Enrollment StartJun 1, 2001
Primary CompletionSep 1, 2008
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 18.5 years ago

Interventions

Standard Wound Dressingprocedure

Group A patients will have a standard dressing applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.

VACdevice

Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.