Wound Infections Following Implant Removal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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See study protocol

Conditions

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Surgical Wound Infection

Keywords

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Implant Removal Antibiotic Prophylaxis Postoperative wound infection Orthopedics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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antibiotic prophylaxis

a single gift of 1000 mg cefazolin in 10 cc of NaCl 0.9% (intervention group)

Group Type ACTIVE_COMPARATOR

Cephalozin

Intervention Type DRUG

1000 mg Cephalozin

No antibiotic prophylaxis

a single gift of 10 cc NaCl 0.9%, given in the same manner (control group).

Group Type PLACEBO_COMPARATOR

Sodium chloride

Intervention Type OTHER

10 cc of NaCl 0.9%

Interventions

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Cephalozin

1000 mg Cephalozin

Intervention Type DRUG

Sodium chloride

10 cc of NaCl 0.9%

Intervention Type OTHER

Other Intervention Names

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Kefzol NaCl 0.9%

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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J.C. Goslings

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manouk Backes, MD, MSc

Role: STUDY_CHAIR

Academic Medical Center/Sint Lucas Andreas Hospital

Tim Schepers, MD, PhD

Role: STUDY_DIRECTOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Schiedam, , Netherlands

Site Status

MC Haaglanden

The Hague, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND

PMID: 24038057 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 25972101 (View on PubMed)

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.

Reference Type DERIVED

PMID: 29279933 (View on PubMed)

Other Identifiers

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NTR 4393

Identifier Type: OTHER

Identifier Source: secondary_id

SB155014

Identifier Type: -

Identifier Source: org_study_id

Wound Infections Following Implant Removal

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

antibiotic prophylaxis

Cephalozin

No antibiotic prophylaxis

Sodium chloride

Interventions

Cephalozin

Sodium chloride

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

AO Research Fund

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Responsible Party

J.C. Goslings

Principal Investigators

Manouk Backes, MD, MSc

Tim Schepers, MD, PhD

Locations

Medisch Centrum Alkmaar

Flevoziekenhuis

Amstelland Ziekenhuis

Academic Medical Center

BovenIJ Ziekenhuis

Onze Lieve Vrouwe Gasthuis

Sint Lucas Andreas Ziekenhuis

VU Medisch Centrum

Gelre Ziekenhuizen

Rode Kruis Ziekenhuis

Amphia Ziekenhuis

Reinier de Graaf

Deventer Ziekenhuis

Catharina Ziekenhuis

Elkerliek Ziekenhuis

Tergooiziekenhuizen

Spaarne Ziekenhuis

Westfries Gasthuis

Rijnland Ziekenhuis

Vlietland Ziekenhuis

MC Haaglanden

Countries

References

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.

Other Identifiers

NTR 4393

SB155014