Clinical trial NCT02225821: Wound Infections Following Implant Removal
Official title: Antibiotic Prophylaxis to Prevent Wound Infections Following Implant Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Wound Infection
Keywords: Implant Removal
Antibiotic Prophylaxis
Postoperative wound infection
Orthopedics
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: AO Research Fund
First posted: 2014-08-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: See study protocol

Eligibility criteria: 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 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

Primary outcomes:
measure: Postoperative wound infection (POWI)
timeFrame: 30 days
Secondary outcomes:
measure: Health-related quality of life
timeFrame: baseline, one month, 6 months
measure: Functional outcome
timeFrame: baseline, 1 month, 6 months
measure: Patient satisfaction
timeFrame: 1 month, 6 months
measure: Health care resources utilization
timeFrame: baseline, 1 month, 6 months
Other outcomes:
measure: Costs
timeFrame: Costs per quality adjusted life year
Locations:
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amstelveen
country: Netherlands
facility: Amstelland Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Amsterdam
country: Netherlands
facility: BovenIJ Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf
city: Den Haag
country: Netherlands
facility: MC Haaglanden
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
city: Hoorn
country: Netherlands
facility: Westfries Gasthuis
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis
city: Schiedam
country: Netherlands
facility: Vlietland Ziekenhuis
Study officials:
affiliation: Academic Medical Center/Sint Lucas Andreas Hospital
name: Manouk Backes, MD, MSc
role: STUDY_CHAIR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Tim Schepers, MD, PhD
role: STUDY_DIRECTOR
References:
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. Epub 2013 Sep 13.
citation: 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.
citation: 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.