Trial document





This trial has been registered retrospectively.
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  DRKS00011505

Trial Description

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Title

presurgical universal decolonisation in native Joint arthroplasty with polyhexanid

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Trial Acronym

PREVENTION

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The opjective of this multicentric cohort study with a historic control is to test if introduction of a universal decolonisation of orthopaedic & traumatological patients receiving native Joint arthroplasty of the knee/hip or spondylodesis/surgery of the lumbar spine influences the rate of surgical site infection.

Patients that are meeting the inclusion criteria and are willing to participate will receive a set with with polyhexanid containing products (wipes, nasal gel, mouth wash), instructions and a questionnaire for evaluation prior to their planned surgery. They will be asked to use the provided set according to instructions 4 days prior to the scheduled surgery. Patients with surgery due to fracture of the femur, will receive two cycles of application.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011505
  •   2017/02/15
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  •   yes
  •   Approved
  •   EA4/124/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   Surgical site infections after primary total joint arthroplasty in native hip-/ knee joints or spondylodesis.
  •   T81.4 -  Infection following a procedure, not elsewhere classified
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Interventions/Observational Groups

  •   Intervention Group: Universal decolonisation of patients that meet the criteria with polyhenid containing washcloths, gel for intranasal application and mouthwash. Products should be used at least twice, but patients with elective surgery should start 4 days Prior to surgery.
  •   Control Group: historic cohort of patients that meet the inclusion and not the exclusion criteria. Those patients were surgically treated in the particpating centers prior to indtroduction of the Quality improvement measure.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Rate of surgical site infections defined in the participating Centers in the german surveillance System for nosocomial infections/ KISS (CDC-definitions).

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Secondary Outcome

questionnaire evaluating Patient satisfaction and safety.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/01/02
  •   4800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Indication for a native joint arthroplasty of the knee/ hip or a spondylodesis/surgery of the lumbar spine.

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Exclusion Criteria

known allergy against polyhexanid or other substances that are present in the decolonisation products. Indication for surgery that is not a native joint arthroplasty of the knee/ hip or a spondylodesis/surgery of the lumbar spine.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Universitätsmedizin BerlinInstitut für Hygiene und Umweltmedizin
    • Ms.  Univ. Prof. Dr. med.  Petra  Gastmeier 
    • Hindenburgdamm 27
    • 12203  Berlin
    • Germany
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    • Charité Universitätsmedizin BerlinInstitut für Hygiene und Umweltmedizin
    • Mr.  Dr. med., MSc  Tobias  Kramer 
    • Hindenburgdamm 27
    • 12203  Berlin
    • Germany
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    • Charité Universitätsmedizin BerlinInstitut für Hygiene und Umweltmedizin
    • Mr.  Dr. med., MSc  Tobias  Kramer 
    • Hindenburgdamm 27
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • B. Braun Medical AGOM-ME-CH05
    • Seesatz 17
    • CH-6204  Sempach
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.