Negative Pressure Wound TherapyNEWTONNCT02739191
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle
A study testing PICO, Smith & Nephew in people with Negative Pressure Wound Therapy and Vacuum Therapy, run by J.C. Goslings at 1 site in Netherlands.
Trial summary
Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Negative Pressure Wound Therapy, Vacuum Therapy, Closed Incisions
- What is being tested?
- PICO, Smith & Nephew
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 and ≤ 80 years
- Orthopedic (trauma) surgery to the foot and/or ankle
- Incision >3 cm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.
- Being tested
- PICO, Smith & Nephew
- Keywords
- NPWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO, Smith & NephewDevice
Direct application of negative pressure wound therapy following Foot and Ankle surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Prophylactic negative pressure wound therapy Receives: Device: PICO, Smith & Nephew |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative Pressure Wound TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- J.C. Goslings
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739191
- Sponsor's protocol ID
- METC 2015_280
- Acronym
- NEWTON
- Status last verified
- Jan 2018
- First submitted
- 9 Apr 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle
- ClinicalTrials.gov ID
- NCT02739191
- Acronym / sponsor ID
- NEWTON / METC 2015_280
- Keywords
- NPWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- J.C. GoslingsUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: PICO, Smith & NephewProphylactic negative pressure wound therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥18 and ≤ 80 years
- Orthopedic (trauma) surgery to the foot and/or ankle
- Incision >3 cm
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICO, Smith & NephewDirect application of negative pressure wound therapy following Foot and Ankle surgery | Device | Intervention |
Primary outcome
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.
2 secondary outcomes
The American Orthopaedic Foot and Ankle Score (AOFAS) will be measured at six months
Time frame: 6 months
EuroQol five dimensions questionnaire (EQ-5D)will be measured at six months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
Related trials for Negative Pressure Wound Therapy
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO, Smith & Nephew in people with Negative Pressure Wound Therapy and Vacuum Therapy, run by J.C. Goslings at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.