Trial document





This trial has been registered retrospectively.
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  DRKS00006753

Trial Description

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Title

Influence of Kinesio-Taping on wound-healing aufter thoracic surgery

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Tapes are routinely used in physiotherapy and orthopedics to treat muscles and tendons. New approaches show that tapes also act on pain receptors in the skin and promote lymphatic drainage.

After cardiothoracic surgery often arise moderate to severe pain.
In this pilot study we want to find out whether the tapes have influence on the perception of pain and the lymphatic drainage after surgery.
For this reason, one group of patients will be tapedon the chest , - outside the wound area.

A second group of patients gets no tapes. At the end of the study, the different values ​​of the patients (analgesics, scores on the pain scale, (...)) are compared.

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Brief Summary in Scientific Language

Cardiothoracic surgeries lead in most cases to moderate to severe pain. The pain is caused the opening and expansion of the chest and by the surgical intervention on the heart and organs (cf. Benedetti et al., 1997). The continous movement of the chest during breathing so produces pain sensations. The respiratory process is often limited in the postoperative phase whereby atelectasis and thereby lung infections are favored.

In a single-center pilot study will be determined if significant differences (pain perception, analgethics, complications) between taped and ungetapeten patients after sternotomy are available.A prospective randomized method will be used therefore.

The patients are divided into two groups. Both groups receive the standard treatment after sternotomy, one of the two groups is additionally treated with Kinesio tape. The skin areas of the lateral chest and below the clavicles will be taped, because there appear significant edemas and hematomas after the surgery.

Goal of this trial is to investigate, if the application of Kinesio tapes can improve the patients' pain ad recovery and reduce the pain killer consumption.

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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

  •   DRKS00006753
  •   2016/02/22
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  •   yes
  •   Approved
  •   4730 R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   Pain after sternotomy
  •   R07.1 -  Chest pain on breathing
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Interventions/Observational Groups

  •   Patients after sternotomy:
    Tape ( Star-shaped Kinesio Tapes on the lateral thorax and below the patients' clavicles during the postoperative hospital stay)
  •   Patients after sternotomy: no tape
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Pain reduction is measured by a pain assessment tool daily during hospitalization.

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Secondary Outcome

Safty and feasability during daily hospital routine is evaluated after the trial by evaluating the needed time and possible adverse effects.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/09/09
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Surgery: Sternotomy

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Exclusion Criteria

Allergy to acrylic glue, parchment skin, psoriasis, sore skin rashes in tapingareas

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Addresses

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    • Klinik für kardiovaskuläre ChirurgieUniversitätsklinikum Düsseldorf
    • Mr.  Prof. Dr.  H.M.  Klein 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Kinesio Vertretung Deutschland - Lucamed
    • Steinbrückstraße 19
    • 79713  Bad Säckingen
    • Germany
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    •   07761 9277947
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    •   [---]*
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    • Universitätsklinikum DüsseldorfKlinik für kardiovaskuläre Chirurgie
    • Mr.  Prof. Dr.  H.M.  Klein 
    • Geb. 12.46 Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Klinik für kardiovaskuläre ChirurgieUniversitätsklinikum Düsseldorf
    • Mr.  Prof. Dr.  H.M.  Klein 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Kinesio Vertretung Deutschland - Lucamed
    • Steinbrückstraße 19
    • 79713  Bad Säckingen
    • Germany
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    •   07761 9277947
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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