- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02739191
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle (NEWTON)
January 17, 2018 updated by: J.C. Goslings
Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, Netherlands, 1105AZ
- Academic Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Prophylactic negative pressure wound therapy
|
Direct application of negative pressure wound therapy following Foot and Ankle surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria.
Time Frame: 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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The American Orthopaedic Foot and Ankle Score (AOFAS) will be measured at six months
Time Frame: 6 months
|
To asses functional outcome of the participants the AOFAS questionnaire will be used
|
6 months
|
EuroQol five dimensions questionnaire (EQ-5D)will be measured at six months
Time Frame: 6 months
|
To asses the quality of life of the participants the EQ-5D questionnaire will be used
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
April 9, 2016
First Submitted That Met QC Criteria
April 12, 2016
First Posted (Estimate)
April 15, 2016
Study Record Updates
Last Update Posted (Actual)
January 19, 2018
Last Update Submitted That Met QC Criteria
January 17, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 2015_280
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Negative Pressure Wound Therapy
-
Memorial Sloan Kettering Cancer Center3M; Miami Cancer InstituteCompletedNegative-Pressure Wound TherapyUnited States
-
University of Toledo Health Science CampusTerminatedNegative-Pressure Wound TherapyUnited States
-
Hillel Yaffe Medical CenterUnknown
-
Ahmed AljomahCompletedWound | Negative Pressure Wound TherapySaudi Arabia
-
National Taiwan University HospitalNot yet recruitingIncisional Negative Pressure Wound TherapyTaiwan
-
3MTerminatedWounds and Injuries | Wound Heal | Wound | Granulation Tissue | Negative-pressure Wound TherapyUnited States
-
University of California, DavisTerminatedRenal Failure | Obese | Kidney Transplant; Complications | Negative Pressure Wound Therapy | Incisional Negative Pressure Wound Therapy | Complications Wounds | Wound Healing Delayed | Incisional | Panniculectomy | Incisional Vac | Wound Vac | Wound Healing ComplicationUnited States
-
University of British ColumbiaUnknownto See Whether Negative Pressure Wound Therapy Decreases Wound Infections.Canada
-
Chinese University of Hong KongRecruitingKnee Arthropathy | Negative Pressure Wound Therapy | Hip ArthropathyHong Kong
-
Ulf Dornseifer, MDCompletedEdema | Microcirculation | Negative-Pressure Wound Therapy | Free Flap | MacrocirculationGermany
Clinical Trials on PICO, Smith & Nephew
-
South Eastern Health and Social Care TrustUnknownNeoplasm Metastasis | Skin Neoplasms | Secondary Malignant Neoplasm of Lymph Node | Non-healing Surgical Wound (Disorder)United Kingdom
-
University of ArizonaCompletedHigh Risk Pregnancy | Cesarean Wound Disruption With Postnatal ComplicationUnited States
-
Skane University HospitalRecruiting
-
University of Southern DenmarkRecruitingAmputation | Wound Heal | Negative-Pressure Wound TherapyDenmark
-
Nova Scotia Health AuthorityWithdrawn
-
University of California, DavisTerminatedRenal Failure | Obese | Kidney Transplant; Complications | Negative Pressure Wound Therapy | Incisional Negative Pressure Wound Therapy | Complications Wounds | Wound Healing Delayed | Incisional | Panniculectomy | Incisional Vac | Wound Vac | Wound Healing ComplicationUnited States
-
Rush University Medical CenterSmith & Nephew, Inc.CompletedRotator Cuff Tear Repair Anchors
-
St. James's Hospital, IrelandUnknownWound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital StayIreland
-
University of AarhusUnknown
-
Carilion ClinicSmith & Nephew, Inc.; DeRoyal Industries, Inc.CompletedImpaired Wound Healing | Postoperative Wound Infection-deepUnited States