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

NCT ID: NCT02739191

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-08-31

Brief Summary

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

Conditions

Negative Pressure Wound Therapy; Vacuum Therapy; Closed Incisions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Prophylactic negative pressure wound therapy

Group Type: EXPERIMENTAL

PICO, Smith & Nephew

Intervention Type: DEVICE

Direct application of negative pressure wound therapy following Foot and Ankle surgery

Interventions

PICO, Smith & Nephew

Direct application of negative pressure wound therapy following Foot and Ankle surgery

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

J.C. Goslings

OTHER

Sponsor Role: lead

Responsible Party

J.C. Goslings

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Academic Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

METC 2015_280

Identifier Type: -

Identifier Source: org_study_id