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| ID | Type | Description | Link |
|---|---|---|---|
| NTR 4393 | Other Identifier | Nederlands Trial Register |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| AO Research Fund | OTHER |
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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.
See study protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antibiotic prophylaxis | Active Comparator | a single gift of 1000 mg cefazolin in 10 cc of NaCl 0.9% (intervention group) |
|
| No antibiotic prophylaxis | Placebo Comparator | a single gift of 10 cc NaCl 0.9%, given in the same manner (control group). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cephalozin | Drug | 1000 mg Cephalozin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | Health-related quality of life (as measured by the EQ-5D questionnaire) | baseline, one month, 6 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manouk Backes, MD, MSc | Academic Medical Center/Sint Lucas Andreas Hospital | Study Chair |
| Tim Schepers, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Centrum Alkmaar | Alkmaar | Netherlands | ||||
| Flevoziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24038057 | Background | 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. | |
| 25972101 | Background | 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. |
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| Sodium chloride | Other | 10 cc of NaCl 0.9% |
|
|
| baseline, 1 month, 6 months |
| Patient satisfaction | Patient satisfaction following implant removal as measured by a ten-point Visual Analog Scale | 1 month, 6 months |
| 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 |
| Almere Stad |
| 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 |
| 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 | Netherlands |
| MC Haaglanden | The Hague | Netherlands |
| 29279933 | Derived | 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. |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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