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

Negative Pressure Wound Therapy Clinical Trial

— NEWTON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739191
• Other study ID #: METC 2015_280
• Status: Completed
• Phase: N/A
• First received: April 9, 2016
• Last updated: January 17, 2018
• Start date: April 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Closed Incisions
• Negative Pressure Wound Therapy
• Surgical Wound
• Vacuum Therapy
• Wounds and Injuries

Intervention

Device:
• PICO, Smith & Nephew
Direct application of negative pressure wound therapy following Foot and Ankle surgery

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
J.C. Goslings

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria.	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.	30 days
Secondary	The American Orthopaedic Foot and Ankle Score (AOFAS) will be measured at six months	To asses functional outcome of the participants the AOFAS questionnaire will be used	6 months
Secondary	EuroQol five dimensions questionnaire (EQ-5D)will be measured at six months	To asses the quality of life of the participants the EQ-5D questionnaire will be used	6 months