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van CCT (UK)

van CCT (UK)

Voorkomen van wondinfecties bij verwijderen van lichaamsvreemd materiaal onder de knie.

- candidate number16017
- NTR NumberNTR4393
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jan-2014
- Secondary IDsNL47722.018.14 CCMO
- Public TitleVoorkomen van wondinfecties bij verwijderen van lichaamsvreemd materiaal onder de knie.
- Scientific TitleAntibiotic prophylaxis and prevention of wound infections following implant removal after foot, ankle and lower leg fractures.
- hypothesisThe incidence of postoperative wound infections following implant removal below the knee joint is lower in patients receiving a preoperative single gift of antibiotic prophylaxis compared to patients without antibiotic prophylaxis.
- Healt Condition(s) or Problem(s) studiedWound infection, Antibiotic prophylaxis, Functional outcome, Implant removal
- Inclusion criteriaImplant removal in foot, ankle and lower leg in patients ≥18 years and ≤75 years of all ethnic backgrounds
- Exclusion criteria- Removing and re-implanting material in the same session - Implant removal due to active infection - Implant removal due to a (plate) fistula - Current antibiotic treatment - Allergy to cephalosporines
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2014
- planned closingdate1-feb-2017
- Target number of participants500
- InterventionsPreoperative single gift of iv antibiotic prophylaxis (Cefalozin)
- Primary outcomeThe primary outcome is the incidence of wound infections (within 30 days after implant removal) as defined by the criteria applied by the CDC and diagnosed by the attending physician.
- Secondary outcomeSecondary outcomes are health-related quality of life (as measured by the EQ-5D), functional outcome (assessed with the Lower Extremity Functional Scale), patient satisfaction (measured by a ten-point Visual Analog Scale), several treatment and function related items (including amongst others, number of visits to the general practitioner and use of home care organizations) measured at 30 days and 6 months postoperatively, as well as costs (e.g. production losses due to sick leave). In addition, the incidence of micro-bacterial growth in cultures taken peroperatively (evaluation between patients with and without antibiotic prophylaxis) and diversity of micro bacterial growth in postoperative wound infection will be documented.
- Timepoints0 days, 30 days, 6 months
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
AO Nederland
- Publications
- Brief summaryIn 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 should be less than 5%. However, rates of 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, we propose a double-blind, placebo-controlled 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 wound infection within 30 days. Secondary outcomes are quality of life, functional outcome at 30 days and 6 months after implant removal and costs. With 2x170 patients a decrease in postoperative wound infections from 12% to 3.3% (expected rate in clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided alpha=5%). If our assumption that prophylactic antibiotics prior to implant removal reduces the infectious complication rate, is confirmed by our 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 wound infections and consequently will lead to less physical and social disability and health care use. A preliminary, conservative estimation suggests yearly cost savings of 3.3 million per year.
- Main changes (audit trail)
- RECORD9-jan-2014 - 10-mrt-2015

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