Trial document





This trial has been registered retrospectively.
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  DRKS00021767

Trial Description

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Title

Scar quality examination comparing titanium-coated suture material and non-coated suture material on flap donor sites in reconstructive surgery

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Prospektive study examining scar quality on flap surgery donor sites after wound closure with titanium coated suture material vs non-titanium coated suture material.

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Brief Summary in Scientific Language

Prospective study comparing scar quality of flap surgery donor sites sutured with titanium coated suture material vs non-titanium-coated suture material. Wound healing is assessed with POSAS scales.

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

No

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Description IPD sharing plan:

not planned

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Organizational Data

  •   DRKS00021767
  •   2020/05/20
  •   [---]*
  •   no
  •   Approved
  •   004/17-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   Scar quality on flap surgery donor sites
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Interventions/Observational Groups

  •   Flap surgery donor site - titanium coated suture
  •   Flap surgery donor site - non-titanium-coated suture
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Comparison of scar quality after use of two different sutures with the help of the POSAS scale (values 1-10) on days 14, 42, 72 and 180, as well as photographical examination

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Secondary Outcome

Superior scar quality with titanium coated suture

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/08/01
  •   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

Flap surgery, given consent

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Exclusion Criteria

no flap surgery, no given consent

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Addresses

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    • Serag Wiessner GmbH & Co. KG
    • Zum Kugelfang 8-12
    • 95119  Naila
    • Germany
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    • Universitätsklinikum Leipzig
    • Mr.  Dr. med  Lukas  Kohler 
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig
    • Mr.  Dr. med.  Lukas  Kohler 
    • Liebigstr. 18
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Serag Wiessner GmbH & Co. KG
    • Mr. 
    • Zum Kugelfang 8-12
    • 95119  Naila
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2020/04/12
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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.