Trial document




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  DRKS00005237

Trial Description

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Title

Does Kinesiologic Tape reduce morbidity after septorhinoplastic?

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Postoperative Morbidity is a major disadvantage after maxillofacial as well as head and neck surgery, often caused by pain, disfunction and swelling affecting patients quality of life. The goal of this study was to find out, whether the application of Kinesiologic Tape (KT) prevents or improves swelling, pain and function after maxillofacial as well as head and neck surgery.

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Brief Summary in Scientific Language

Postoperative Morbidity is a major disadvantage after maxillofacial as well as head and neck surgery, often caused by pain, disfunction and swelling affecting patients quality of life.
Several methods to control the immediate inflammatory response associated with maxillofacial as well as head and neck surgery have been performed and reported: these modalities include the use of drugs such as analgesics, corticosteroids, antibiotics and proteolytic enzymes; laser application, or physical therapeutic methods like cryotherapy or manual lymph drainage (MLD). However, no single modality significantly prevents the occurrence of these complications without possible undesirable side effects or considerable costs. Therefore, further techniques for a better pain, swelling and function control are needed for patients who undergo maxillofacial as well as head and neck surgery.
Kinesiologic Tape (KT) is an elastic therapeutic tape with its origins in sports science. Developed by Dr. K. Kase in the 1970s, KT techniques are claimed to support injured muscles and joints, helping to relieve pain. Furthermore, the use of KT in the management of lymphedema is gaining popularity. The general idea is that KT is lifting the skin thus improving blood and lymph flow, removing congestions of lymphatic fluid or hemorrhages. Providing space fluids are encouraged to move from areas of higher pressure towards areas of lower pressure, guided by the tape to the desired direction of drainage . However, there is a significant clinical and practical experience in this approach but little published controlled research. Using this technique might be beneficial for postoperative management after head and neck surgery, accelerating drainage of tissue reaction or hemorrhages.
The goal of this study was to find out, whether the application of Kinesiologic Tape (KT) prevents or improves swelling, pain and function after maxillofacial as well as head and neck surgery.

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Organizational Data

  •   DRKS00005237
  •   2013/08/21
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  •   yes
  •   Approved
  •   056-13, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   NASENSEPTUMDEVIATION
  •   J34.2 -  Deviated nasal septum
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Interventions/Observational Groups

  •   Septorhinoplastic with tape application
  •   Septorhinoplastic without tape application
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint is swelling reduction one day after maximum swelling. Swelling was assed by a five-line measurement at six specific time points (T): Preoperative (T-1), Baseline (BL)=directly after operation (T0), first (T1), second (T2), third (T3) and seventh (T4) postoperative days.

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Secondary Outcome

Secundary endpoint is time of maximum swelling, increase of swelling after operation, pain score, subjective analysis as well nasal air flow function.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2013/09/12
  •   100
  •   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

operation indication for septorhinoplastic

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Exclusion Criteria

Allergies on tape; strong beard growth; under age

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Addresses

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    • Abteilung für Hals-, Nasen- und Ohrenheilkunde, Klinikum Dachau
    • Ms.  PD Dr. med.  Michaela  Andratschke 
    • Krankenhausstrasse 15
    • 85221  Dachau
    • Germany
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    • LMU München, Zahnmedizinische Fakultät
    • Mr.  Dr. med.  Oliver  Ristow 
    • Göthestraße 70
    • 80336  München
    • Germany
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    • Abteilung für Hals-, Nasen- und Ohrenheilkunde, Klinikum Dachau
    • Ms.  PD Dr. med.  Michaela  Andratschke 
    • Krankenhausstrasse 15
    • 85221  Dachau
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Hals-, Nasen- und Ohrenheilkunde, Klinikum Dachau
    • Ms.  PD Dr. med.  Michaela  Andratschke 
    • Krankenhausstrasse 15
    • 85221  Dachau
    • Germany
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    •   +49.8131.764900
    •   +49. 8131.764909
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    • LMU München, Zahnmedizinische Fakultät
    • Mr.  Dr. med.  Oliver  Ristow 
    • Göthestraße 70
    • 80336  München
    • Germany
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Status

  •   Recruiting planned
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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.