Back to resultsNegative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle (NEWTON)
Primary Purpose
Negative Pressure Wound Therapy, Vacuum Therapy, Closed Incisions
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PICO, Smith & Nephew
Sponsored by
About this trial
This is an interventional prevention trial for Negative Pressure Wound Therapy focused on measuring NPWT
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
Sites / Locations
- Academic Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Prophylactic negative pressure wound therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02739191
Brief Title
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle
Acronym
NEWTON
Official Title
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
J.C. Goslings
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative Pressure Wound Therapy, Vacuum Therapy, Closed Incisions
Keywords
NPWT
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Prophylactic negative pressure wound therapy
Intervention Type
Device
Intervention Name(s)
PICO, Smith & Nephew
Intervention Description
Direct application of negative pressure wound therapy following Foot and Ankle surgery
Primary Outcome Measure Information:
Title
Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria.
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The American Orthopaedic Foot and Ankle Score (AOFAS) will be measured at six months
Description
To asses functional outcome of the participants the AOFAS questionnaire will be used
Time Frame
6 months
Title
EuroQol five dimensions questionnaire (EQ-5D)will be measured at six months
Description
To asses the quality of life of the participants the EQ-5D questionnaire will be used
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle
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