Wound Infections Following Implant Removal

Surgical Wound Infection Clinical Trial

— WIFI  

Official title:

Antibiotic Prophylaxis to Prevent Wound Infections Following Implant Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225821
• Other study ID #: SB155014
• Secondary ID: NTR 4393
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2014
• Last updated: December 21, 2016
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical 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%. 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.

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.

Description:

See study protocol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients =18 years and =75 years of all ethnic backgrounds

• Implant removal following foot, ankle and/or lower leg surgery

Exclusion Criteria:

• 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 ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Drug:
• Cephalozin
1000 mg Cephalozin

Other:
• Sodium chloride
10 cc of NaCl 0.9%

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Flevoziekenhuis	Almere
Netherlands	Amstelland Ziekenhuis	Amstelveen
Netherlands	Academic Medical Center	Amsterdam
Netherlands	BovenIJ Ziekenhuis	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Sint Lucas Andreas Ziekenhuis	Amsterdam
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Gelre Ziekenhuizen	Apeldoorn
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Reinier de Graaf	Delft
Netherlands	MC Haaglanden	Den Haag
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Elkerliek Ziekenhuis	Helmond
Netherlands	Tergooiziekenhuizen	Hilversum
Netherlands	Spaarne Ziekenhuis	Hoofddorp
Netherlands	Westfries Gasthuis	Hoorn
Netherlands	Rijnland Ziekenhuis	Leiderdorp
Netherlands	Vlietland Ziekenhuis	Schiedam

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	AO Research Fund, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Costs	Costs (economic evaluation including budget impact analysis): the economic evaluation of antibiotic prophylaxis in patients scheduled for implant removal (following a foot, ankle or lower leg fracture) against no prophylaxis as its best alternative will be performed as a cost-effectiveness (CEA) as well as a cost-utility (CUA) analysis.	Costs per quality adjusted life year	No
Primary	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.	30 days	No
Secondary	Health-related quality of life	Health-related quality of life (as measured by the EQ-5D questionnaire)	baseline, one month, 6 months	No
Secondary	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	baseline, 1 month, 6 months	No
Secondary	Patient satisfaction	Patient satisfaction following implant removal as measured by a ten-point Visual Analog Scale	1 month, 6 months	No
Secondary	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).	baseline, 1 month, 6 months	No