CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 249 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/NCT00582998
NCT00582998N/ACompleted
CompareCT.gov

Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries Sustained as a Result of Calcaneus, Tibial Plateau and Pilon Fractures

University of Alabama at Birmingham·interventional·Posted Dec 28, 2007·Updated Jul 25, 2019

In Brief

A clinical study evaluating Standard Wound Dressing and Vacuum Assisted Closure Device for Fracture of Calcaneus, Pilon or Tibial Plateau. Completed, enrolled 249 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 soft tissue injuries and the surgical incision following open reduction and internal fixation of calcaneus, tibial plateau, and pilon fractures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFracture of Calcaneus, Pilon or Tibial Plateau
CountriesUnited States
CollaboratorsKCI USA, Inc

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2007
Enrollment StartJun 1, 2001
Primary CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.5 years ago

Interventions

Standard Wound Dressingprocedure

Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact.

Vacuum Assisted Closure Devicedevice

Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact.