Prevention of wound infections in implant removal following fracture surgery in the foot, ankle and lower leg.

Conditions: Postoperative wound infection following implant removal below the knee
Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

Registration Number: EUCTR2014-000124-14-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Consecutive patients of all ethnic backgrounds, aged 18 to 75 years, scheduled for implant removal
following foot, ankle and/or lower leg fracture surgery are included after written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are: removal and re-implanting of osteosynthetic material in the same session; an 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; insufficient comprehension of the Dutch language to understand the patient information to make an informed decision to participate.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: the objective is to study the (cost-)effectiveness of a single intravenous gift of antibiotic<br>prophylaxis with a first generation cephalosporin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures;Secondary Objective: Health-related quality of life, functional outcome, health care utilization, including transmural care, and costs from a health care and societal perspective (secondary outcomes).;Primary end point(s): A POWI within 30 days after implant removal as defined by the criteria applied by the CDC and diagnosed by the attending physician.;Timepoint(s) of evaluation of this end point: 30 days postoperatively

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcomes include:<br>-health-related quality of life as measured by the EQ-5D questionnaire. <br>-difference in functional outcome as assessed with the Lower Extremity Functional Scale (LEFS).<br>-patient satisfaction as measured by a ten-point Visual Analog Scale.<br>-health care resources utilization (including amongst others, number of visits to the general practitioner and use of home care organizations) as measured by way of a combination of patient questionnaires <br>-costs (economic evaluation including budget impact analysis);Timepoint(s) of evaluation of this end point: 0 days, 1 month, 6 months