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

• Register: EUCTR
• Last refreshed on: 24 November 2014
• Main ID: EUCTR2014-000124-14-NL
• Date of registration: 21/10/2014
• Prospective Registration: Yes
• Primary sponsor: Academic Medical Center
• Public title: Prevention of wound infections in implant removal following fracture surgery in the foot, ankle and lower leg.
• Scientific title: Antibiotic prophylaxis to prevent wound infections following implant removal after foot, ankle and lower leg fractures. - WIFI trial
• Date of first enrolment: 21/10/2014
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000124-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Sodiumchloride 0.9% Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands

Contacts

• Name: Trauma Unit
• Affiliation: Academic Medical Center

• Name: Trauma Unit
• Affiliation: Academic Medical Center

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Postoperative wound infection following implant removal below the knee

Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

Intervention(s)

Trade Name: Cefalozin
Product Name: Kefzol
Product Code: RVG 25307
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: CEFAZOLIN SODIUM
CAS Number: 27164-46-1
Current Sponsor code: 1-20223
Other descriptive name: CEFAZOLIN SODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.028-

Primary Outcome(s)

Main Objective: the objective is to study the (cost-)effectiveness of a single intravenous gift of antibiotic
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(s)

Timepoint(s) of evaluation of this end point: 0 days, 1 month, 6 months

Secondary end point(s): Secondary outcomes include:
-health-related quality of life as measured by the EQ-5D questionnaire.
-difference in functional outcome as assessed with the Lower Extremity Functional Scale (LEFS).
-patient satisfaction as measured by a ten-point Visual Analog Scale.
-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
-costs (economic evaluation including budget impact analysis)

Secondary ID(s)

NL47077

NTR 4393

Source(s) of Monetary Support

Stichting AO Nederland