NCT00582998

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
11.6 years until next milestone

Results Posted

Study results publicly available

July 25, 2019

Completed
Last Updated

July 25, 2019

Status Verified

May 1, 2019

Enrollment Period

5.8 years

First QC Date

December 20, 2007

Results QC Date

March 31, 2017

Last Update Submit

May 28, 2019

Conditions

Fracture of Calcaneus, Pilon or Tibial Plateau

Keywords

Vacuum Assisted Closure (VAC)Calcaneus FracturePilon FractureTibial Plateau FractureOpen Reduction and Internal Fixation

Outcome Measures

Primary Outcomes (1)

  • Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau)

    Healing of Orthopaedic Trauma Extremity Wounds: Calcaneus, Pilon and Tibial Plateau Fractures with standard dressing versus negative pressure wound therapy

    The time from injury from surgical stabilization (14 days)

Study Arms (2)

Standard Wound Dressing

ACTIVE COMPARATOR

Standard post-operative wound dressing

Procedure: Standard Wound Dressing

Vacuum Assisted Closure Device

ACTIVE COMPARATOR

Vacuum Assisted Closure (VAC) device

Device: Vacuum Assisted Closure Device

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.

Standard Wound Dressing
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.

Also known as: Vacuum Assisted Closure (VAC) device
Vacuum Assisted Closure Device

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have a closed calcaneus, tibial plateau or pilon fracture requiring open reduction and internal fixation.
  • Adult patients (19 years and older)

You may not qualify if:

  • No clinical evidence of infection
  • Patients unable or unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

  • Tarkin IS, Clare MP, Marcantonio A, Pape HC. An update on the management of high-energy pilon fractures. Injury. 2008 Feb;39(2):142-54. doi: 10.1016/j.injury.2007.07.024. Epub 2007 Dec 3.

    PMID: 18054017BACKGROUND

  • Thompson JT, Marks MW. Negative pressure wound therapy. Clin Plast Surg. 2007 Oct;34(4):673-84. doi: 10.1016/j.cps.2007.07.005.

    PMID: 17967622BACKGROUND

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Results Point of Contact

Title
Asya Love, RN
Organization
University of Alabama at Birmingham
asyalove@uab.edu
205-996-6781

Study Officials

  • Steven M Theiss, MD

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 28, 2007

Study Start

June 1, 2001

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

July 25, 2019

Results First Posted

July 25, 2019

Record last verified: 2019-05

Locations

US(1)