Closed Incisions, Negative Pressure Wound Therapy, Vacuum Therapy
Conditions
Keywords
NPWT
Brief summary
Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.
Interventions
DEVICEPICO, Smith & Nephew
Direct application of negative pressure wound therapy following Foot and Ankle surgery
Sponsors
J.C. Goslings
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 and ≤ 80 years * Orthopedic (trauma) surgery to the foot and/or ankle * Incision \>3 cm
Exclusion criteria
* Open fractures * Antibiotic treatment at the time of the operation for a concomitant disease or infection * Insufficient comprehension of the Dutch language * Patients with immune-deficiencies * Inability to address negative pressure wound therapy device * Active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria. | 30 days | The number of POWI's within 30 days of surgery will be recorded. These will be classified in superficial and deep POWI's using the criteria as proposed by the CDC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol five dimensions questionnaire (EQ-5D)will be measured at six months | 6 months | To asses the quality of life of the participants the EQ-5D questionnaire will be used |
| The American Orthopaedic Foot and Ankle Score (AOFAS) will be measured at six months | 6 months | To asses functional outcome of the participants the AOFAS questionnaire will be used |
Countries
Netherlands
Outcome results
None listed