N/A
N=249
Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries
Fracture of Calcaneus, Pilon or Tibial Plateau
Bottom Line
View on ClinicalTrials.gov: NCT00582998 ↗Enrolled (actual)
249
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau) — 99; 127 Fractures
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Wound Dressing (Procedure); Vacuum Assisted Closure Device (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau) |
99; 127 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients who have a closed calcaneus, tibial plateau or pilon fracture requiring open reduction and internal fixation.
- Adult patients (19 years and older)
Exclusion Criteria
- No clinical evidence of infection
- Patients unable or unwilling to give informed consent
Data sourced from ClinicalTrials.gov (NCT00582998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.