Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle (NEWTON)

J.C. Goslings

Status: Completed

Conditions: Negative Pressure Wound Therapy; Closed Incisions; Vacuum Therapy

Treatments: Device: PICO, Smith & Nephew

Study type: Interventional

Funder types: Other

Identifiers

NCT02739191

METC 2015_280

Details and patient eligibility

About

Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intervention

Experimental group

Description:

Prophylactic negative pressure wound therapy

Treatment:

Device: PICO, Smith & Nephew