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

Not Applicable

Completed

• Conditions: Vacuum Therapy; Closed Incisions; Negative Pressure Wound Therapy
• Interventions: Device: PICO, Smith & Nephew

• Registration Number: NCT02739191
• Lead Sponsor: J.C. Goslings

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-09
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Primary Completion: 2017-03
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	PICO, Smith & Nephew	Prophylactic negative pressure wound therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands