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Surgical Wound InfectionPhase 4WIFINCT02225821

Wound Infections Following Implant Removal

A Phase 4 study testing Cephalozin and Sodium chloride in people with Surgical Wound Infection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 21 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the Netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWIs) should be less than 5%. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Surgical Wound Infection
What is being tested?
Cephalozin and Sodium chloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
21 sitesNetherlands
Study dates
Nov 2014to Nov 2016
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥18 years and ≤75 years of all ethnic backgrounds
  • Implant removal following foot, ankle and/or lower leg surgery

Who cannot join

  • Removing and re-implanting osteosynthesis material in the same session
  • Active wound infection or (plate) fistula
  • Antibiotic treatment at time of elective implant removal for a concomitant disease or infection
  • A medical history of an allergic reaction to a cephalosporin, penicillin, or any other β-lactam antibiotic.
  • Insufficient comprehension of the Dutch language to understand the patient information to make an informed decision to participate.
  • Kidney disease (eGFR <60 ml/min/1.73m^2).
  • Treatment with probenecide, anticoagulants (see SPC)
  • Pregnancy and lactation

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Netherlands21 sites

  • Medisch Centrum Alkmaar

    Alkmaar

  • Flevoziekenhuis

    Almere Stad

  • Amstelland Ziekenhuis

    Amstelveen

  • Academic Medical Center

    Amsterdam

  • BovenIJ Ziekenhuis

    Amsterdam

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam

  • Sint Lucas Andreas Ziekenhuis

    Amsterdam

  • VU Medisch Centrum

    Amsterdam

  • Gelre Ziekenhuizen

    Apeldoorn

  • Rode Kruis Ziekenhuis

    Beverwijk

  • Amphia Ziekenhuis

    Breda

  • Reinier de Graaf

    Delft

  • Deventer Ziekenhuis

    Deventer

  • Catharina Ziekenhuis

    Eindhoven

  • Elkerliek Ziekenhuis

    Helmond

  • Tergooiziekenhuizen

    Hilversum

  • Spaarne Ziekenhuis

    Hoofddorp

  • Westfries Gasthuis

    Hoorn

  • Rijnland Ziekenhuis

    Leiderdorp

  • Vlietland Ziekenhuis

    Schiedam

  • MC Haaglanden

    The Hague

Other trials in Netherlands

About this study

Official title: Antibiotic Prophylaxis to Prevent Wound Infections Following Implant Removal

In the Netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWIs) should be less than 5%. However, rates of 10-12% following implant removal, specifically after foot, ankle and lower leg fractures are reported. Currently, surgeons decide individually if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation.

Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in patients scheduled for implant removal following a foot, ankle or lower leg fracture, to assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome at 30 days and 6 months after implant removal and costs.

Read more

With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided alpha=5%, including 15% lost to follow up).

If the assumption of the investigators, that prophylactic antibiotics prior to implant removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of care. This will reduce the incidence of POWIs and consequently will lead to less physical and social disabilities and health care use. In addition, it will decrease the rate of use of empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of €3.5 million per year.

Read the detailed description

See study protocol

Being tested
Cephalozin, Sodium chloride
Keywords
Implant Removal, Antibiotic Prophylaxis, Postoperative wound infection, Orthopedics
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CephalozinDrug

    Also called Kefzol

    1000 mg Cephalozin

  • Sodium chlorideOther

    Also called NaCl 0.9%

    10 cc of NaCl 0.9%

Study groups in NCT02225821
Study groupRoleWhat they receive
antibiotic prophylaxisActive comparatora single gift of 1000 mg cefazolin in 10 cc of NaCl 0.9% (intervention group)
Receives: Drug: Cephalozin
No antibiotic prophylaxisPlacebo comparatora single gift of 10 cc NaCl 0.9%, given in the same manner (control group).
Receives: Other: Sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative wound infection (POWI)

    The primary outcome variable is a POWI within 30 days after implant removal as defined by the criteria applied by the Centers for Disease and Control.

    Measured: 30 days

Secondary outcomes (4)

  1. Health-related quality of life

    Health-related quality of life (as measured by the EQ-5D questionnaire)

    Measured: baseline, one month, 6 months

  2. Functional outcome

    Functional outcome following implant removal as assessed with the Lower Extremity Functional Scale (LEFS). The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention

    Measured: baseline, 1 month, 6 months

  3. Patient satisfaction

    Patient satisfaction following implant removal as measured by a ten-point Visual Analog Scale

    Measured: 1 month, 6 months

  4. Health care resources utilization

    Health care resources utilization at baseline, 1 month and 6 months after implant removal (including amongst others, number of visits to the general practitioner and use of home care organizations) as measured by way of a combination of the Dutch iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) (adapted to the study setting).

    Measured: baseline, 1 month, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02225821
Sponsor's protocol ID
SB155014
Other IDs
NTR 4393
Acronym
WIFI
Status last verified
Dec 2016
First submitted
25 Aug 2014
Last updated
22 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Backes M, Schep NW, Luitse JS, Goslings JC, Schepers T. Indications for implant removal following intra-articular calcaneal fractures and subsequent complications. Foot Ankle Int. 2013 Nov;34(11):1521-5. doi: 10.1177/1071100713502466. Epub 2013 Sep 13.

    PubMed 24038057

  • Backes M, Dingemans SA, Schep NW, Bloemers FW, Van Dijkman B, Garssen FP, Haverlag R, Hoogendoorn JM, Joosse P, Mirck B, Postma V, Ritchie E, Roerdink WH, Sintenie JB, Soesman NM, Sosef NL, Twigt BA, Van Veen RN, Van der Veen AH, Van Velde R, Vos DI, De Vries MR, Winkelhagen J, Goslings JC, Schepers T. Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial. BMC Surg. 2015 Feb 6;15:12. doi: 10.1186/1471-2482-15-12.

    PubMed 25972101

  • Backes M, Dingemans SA, Dijkgraaf MGW, van den Berg HR, van Dijkman B, Hoogendoorn JM, Joosse P, Ritchie ED, Roerdink WH, Schots JPM, Sosef NL, Spijkerman IJB, Twigt BA, van der Veen AH, van Veen RN, Vermeulen J, Vos DI, Winkelhagen J, Goslings JC, Schepers T; WIFI Collaboration Group. Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial. JAMA. 2017 Dec 26;318(24):2438-2445. doi: 10.1001/jama.2017.19343.

    PubMed 29279933

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cephalozin and Sodium chloride in people with Surgical Wound Infection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 21 sites 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 2 inclusion and 8 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 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Postoperative wound infection (POWI) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02225821, which also lists 3 linked publications.

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 22 Dec 2016.

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