Trial document





This trial has been registered retrospectively.
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  DRKS00005251

Trial Description

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Title

Monocentric two-arm, non-randomized study to investigate biochemical and physiologic parameters and their correlation to the clinical appearance during negative pressure wound therapy with the aim to determine the appropriate moment to switch to the subsequent therapy

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Trial Acronym

Early Switch

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Due to the high efforts for the clinic as well as for the patient (frequent dressing changes in the operation theatre, anesthesia) the question raises how long NPWT (negative pressure wound therapy) should be used and when this therapy could have been switched to an alternative less complex and less stressful therapy.
The aim of the study is to determine a time point when a switch from negative pressure therapy to a less expensive and less stressful therapy is possible. Generally the switch occurs when the wound is covered with more than 75 % granulation tissue. It is hypothesized in this study that the switch may occur at an earlier time point. Study participants are patients with wounds with or without infection.
Amendment 3 from December 21th 2013: The assignment of patients with or without infected wounds was performed before inclusion by means of clinical signs of infection and by microbial swabs. However, patients often get antibiotic therapy before the start of the negative ressure therapy in that a positive swab result can not be expected though signs of infection are present. According to the new protocol version the assignment will be carried out at the end of the study by means of the clinical documentation. The asssignement is performed by those persons who later select the patients for biochemical analyses. 2) At the end of the study 5 patienst with infection as well as 5 patients wihout infection should be selected. For the biochemical analysis those patients should be selected that have passed the treatment without protocol violation, whose treatment process was fully documented and who could be assigned to one of the study arms. Experience has shown, that these conditions are often not realized. Therefore we increased the number of study patients from 20 to 30 in order to have a real chance to obtain 5 patients in each group.

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Brief Summary in Scientific Language

Biochemical and physiologic parameters as well as the clinical appearance of the wound are studied during the course of the negative pressure wound therapy in order to determine indications for an appropriate switch to an alterantive less complex therapy.

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Organizational Data

  •   DRKS00005251
  •   2013/08/23
  •   [---]*
  •   no
  •   Approved
  •   188/12, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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Health Condition or Problem studied

  •   Acute wounds
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Interventions/Observational Groups

  •   Wounds are treated with negative pressure wound thearpy and at the study end will be assigned to wounds whose healing progress was influenced by infection.
  •   Wounds are treated with negative pressure and at the study end wounds will be assigned to wounds whose healing progress was not influenced by infection.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

In order to determine the appropriate time point for switching to an alternative therapy the wound status will be evaluated by means of a wound score. This should be done at the first dressing application, at all dressing changes and at the last dressing application. In addition, wound exudates will be collected during every dressing change and analysed biochemically. Physiologic status will be determined by routine laboratory-analysed findings.

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Secondary Outcome

secondary endpoints not defined

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/11
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Men and women at least 18 years old
- The patient has given his consent which he had signed and dated by himself.
Patient suffered from a wound which should be treated with the NPWT system Vivano according to the estimation of the investigator and according to the the manufacturer's instructions. Three dressing changes should be planed according to the estimation of the physician.
- Expectancy of life of the patient should exceed four weeks.

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Exclusion Criteria

- Patient suffers from an infection concerning the immune system and/or can be transmitted by blood
- Patient with known diabetes and Hba1c > 64 mmol/l
- Patient suffers from an active autoimmune deficiency which is inadequately compensated by therapy at the start of the study.
- Patient receives cytostatics due to an oncologic disease
- Patient is immune suppressed due to a preceeding organ transplantation
- Patient requires dialysis before the start of the study.
- Patient presents signs of malnutrition, i.e. BMI < 17 and/or albumin level < 25 g/l.
- Patient suffers from adipositas permagna with a BMI > 40.
- Patient is according to the investigator not capable of understanding the character, meaning and consequences of the clinical study.
- Preceeding participation at this study as well as participation at another study within 4 weeks before the start of the study. An exception is the study which had been approved by the ethics commitee by the number 185/08.
- Patient is pregnant or breast-feeding.

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Addresses

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    • PAUL HARTMANN AG
    • Paul-Hartmann-Str. 12
    • 89522  Heidenheim
    • Germany
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    • ETH Zürich Institute of Molecular Health SciencesHPM D23.2
    • Mr.  Dr.  Ulrich  Auf dem Keller 
    • Schafmattstr. 18
    • 8093  Zürich
    • Switzerland
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    • PAUL HARTMANN AG
    • Ms.  Dr.  Daniela  Kaspar 
    • Paul-Hartmann-Str. 12
    • 89522  Heidenheim
    • Germany
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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie Universitätsklinikum des Saarlandes
    • Mr.  Professor  Tim  Pohlemann 
    • Kirrbergerstraße, Gebäude 57
    • 66421  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • PAUL HARTMANN AG
    • Paul-Hartmann-Straße 12
    • 89522  Heidenheim
    • Germany
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Status

  •   Recruiting ongoing
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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.