Trial document




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  DRKS00006293

Trial Description

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Title

Comparison of wound treatment and wound healing with a hyaluronic acid-containing matrix vs. hydrofibre and skin transplant healing rates for defect coverage after resection of skin tumors

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Trial Acronym

[---]*

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URL of the Trial

http://www.fachklinik-hornheide.de/Studien-der-Plastischen-Chirur.371.0.html

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Brief Summary in Lay Language

Background: In this study the results of different wound therapeutics in so called open wound therapy followed by autologous skin grafting are compared after the excision of skin tumors.
What is done? Who are potential participants?
All adults aged 18 years onwards, in need of excision of a skin tumor and skin grafting can participate in the study.
Aims of the study:
Evidence based evaluation of two different methods for the promotion of granulation tissue and dermal regenaration. So far there is no proof that bio-inductive hyaluronic acid based dermal subsitutes initiates a better wound healing process in comparison to hydrofibre wound dressings. The effects of hyaluronic acid and hydrofibres in wound healing and the molecular processes will be examined.
The wound therapeutics to be compared are Hyalomatrix (Anika Wound Therapeutics S.r.l.) and Aquacel Hydrofibre (Convatec).
Hypothesis: The use of Hyalomatrix leads to less scarring and a better skin texture be promoting coordinatetd cell growth in the three dimensional stuctrue of the hyaluronic acid fibres.

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Brief Summary in Scientific Language

The results of wound treatment after excision of skin tumours with two different wound therapeutics are compared.The are a bio inductive, hyaluronic acid based three dimensional dermal substitute (Hylomatix, Anika Wound therapuetics S.r.l.) and a hydrofibre (Aquacel extra, Convatec)

Objective analysis of the results is achieved with skin ultrasound photo documentation, visual pain scale and the POSAS scar scale.

Histo-pathological examinations will by performed to morphologically evaulate and quantify wound healing and angiogenesis aspects.
H&E colouring and Antibodies against endothelium as well as the markers CD34 und SMA will be used. The fibrillar collagen is quantified by EvG colouring.

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Organizational Data

  •   DRKS00006293
  •   2014/07/03
  •   [---]*
  •   no
  •   Approved
  •   2014-148-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1158-9113 
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Health Condition or Problem studied

  •   C43 -  Malignant melanoma of skin
  •   C44 -  Other malignant neoplasms of skin
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Interventions/Observational Groups

  •   After tumor excision wound treatment with Hyalomatrix (Anika Therapeutics S.r.l) followed by autologous skin graft
  •   After tumor excision open wound treatment with Aqaucel (Convatec) followed by autologous skin graft
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Skin transplant take rate 1 week after grafting, as well as after 6-12 months. Scar evaluation with POSAS scar scale and high resolution skin ultrasound examination

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Secondary Outcome

Pain during wound dressing after tumor excision with visual analog pain scale (VAS)
scar quaulity (POSAS scar scale) 6-12 months after skin grafting

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/07/14
  •   52
  •   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

Skin Tumor in need of excision and skin transplantation

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Exclusion Criteria

Persons aged under 18, Wound infection before surgery, missing informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • ATG-Med, AT Technologies GmbH
    • Mr.  Tolga  Halici 
    • Schwanen 10
    • 42929  Wermelskirchen
    • Germany
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    • Fachklinik HornheideAbteilung für Plastische und Ästhetische Chirurgie, Handchirurgie
    • Mr.  Dr. med  Albrecht  Krause-Bergmann 
    • Dorbaumstr. 300
    • 48157  Münster
    • Germany
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    • Fachklinik HornheideAbteilung für Plastische und Ästhetische Chirurgie, Handchirurgie
    • Mr.  Dr. med  Albrecht  Krause-Bergmann 
    • Dorbaumstr. 300
    • 48157  Münster
    • Germany
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Sources of Monetary or Material Support

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    • AT Technologies GmbH
    • Mr.  Tolga  Halici 
    • Schwanen 10
    • 42929  Wermelskirchen
    • Germany
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    • Fachklinik HornheideAbteilung für Plastische und Ästhetische Chirurgie, Handchirurgie
    • Mr.  Dr. med  Albrecht  Krause-Bergmann 
    • Dorbaumstr. 300
    • 48157  Münster
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2016/04/30
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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.