N/A
Completed N=63
Vacuum Assisted Closure as a Treatment for Open Fractures
Orthopaedic Traumatic Open Fractures
Source: ClinicalTrials.gov NCT00582361 ↗
Enrolled (actual)
63
Serious AEs
7.9%
Results posted
Jan 2013
Primary outcomePrimary: Healing of Orthopaedic Trauma Open Fractures — 3.2; 4.0 use days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Healing of Orthopaedic Trauma Open Fractures |
3.2; 4.0 | — |
| PRIMARY Infections |
7; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient who has sustained an open fracture that requires surgical irrigation and debridement.
- No gross clinical evidence of infection.
Exclusion Criteria
- A grossly infected open wound. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any wounds that are thought to be infected will be cultured to confirm the diagnosis.
- A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such as Ioban or Tegaderm) to achieve a closed vacuum environment over the wound.
- Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
- Abnormal coagulation leading to an expanding hematoma that will require surgical debridement.
- Pregnant women.
- Inability or unwillingness to comply with protocol.
- Patients or family members who are unable or unwilling to sign study informed consent.
Data sourced from ClinicalTrials.gov (NCT00582361). 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. Informational only — not medical advice.