Trial document





This trial has been registered retrospectively.
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  DRKS00004846

Trial Description

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Title

3D evaluation of postoperative swelling in treatment of zygomatic bone fractures using 2 different cooling therapy methods:
- A randomized observer blind prospective study –

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Trial Acronym

Cooling therapy in treatment of zygomatic fractures

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study was to compare post-operative cooling therapy applied through the use of cooling compresses with the water-circulating cooling face mask by Hilotherm® in terms of beneficial impact on postoperative facial swelling, pain, eye motility, diplopia, neurological complaints and patient satisfaction.

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Brief Summary in Scientific Language

Background: Surgical treatment and complications of patients with zygomatic bone fractures can lead to a significant degree of tissue trauma resulting in common postoperative symptoms and types of pain, facial swelling and functional impairment. Beneficial effects of local cold treatment on postoperative swelling, edema, pain, inflammation, haemorrhage as well as the reduction of metabolism, bleeding and hematomas have been described.
The aim of this study was to compare post-operative cooling therapy applied through the use of cooling compresses with the water-circulating cooling face mask by Hilotherm® in terms of beneficial impact on postoperative facial swelling, pain, eye motility, diplopia, neurological complaints and patient satisfaction.
Methods: 42 patients were selected for treatment of unilateral zygomatic bone fractures and were divided randomly to one of two treatments either a Hilotherm® cooling face mask or conventional cooling compresses. Cooling was initiated as soon as possible after surgery until postoperative day 3 and was applied continuously for 12 hours daily. Facial swelling was quantified through a 3D optical scanning technique. Furthermore, pain, neurological complaints, eye motility, diplopia and patient satisfaction were observed from each patient.
Results: Patients receiving a cooling therapy by Hilotherm® demonstrated significantly less facial swelling, less pain, reduced limitation of eye motility and diplopia, fewer neurological complaints and were more satisfied compared to patients receiving conventional cooling therapy.
Conclusions: Hilotherapy is more efficient in managing postoperative swelling and pain after treatment of unilateral zygomatic bone fractures compared to conventional cooling.

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Organizational Data

  •   DRKS00004846
  •   2013/03/26
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  •   yes
  •   Approved
  •   CIS-EK 142/2008, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

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Health Condition or Problem studied

  •   S02.4 -  Fracture of malar and maxillary bones
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Interventions/Observational Groups

  •   21 patients were treated with conventional cooling after reposition of unilateral zygomatic bone fractures
  •   21 patients received continuous cooling using hilotherapy after reposition of unilateral zygomatic bone fractures
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

swelling: 3D optical scans were recorded at 6 points in time: on the 1st day after surgery (T1), on the 2nd (T2), the 3rd (T3), the 7th (T4) and the 28th (T5) and the 90th (T6) postoperative day
pain: 10-point visual analogue scale (VAS) based on measurements before surgery (T0), on the 1st (T1), 2nd (T2) and 7th (T3) day after operation
eye motility and diplopia: For the analysis of eye motility and diplopia the patient was required to fix a light source at a distance of 30 cm. While the head was fixed, the light source was guided in different directions of view. The relative displacement of the reflected images to each other and the movement of the eye were analyzed. Meanwhile, the patient was asked about diplopia. The data were collected at 4 points in time: before surgery (T0), on the 1st (T1), the 7th (T2) and the 28th (T3) postoperative day.
neurological complaints: The skin of the upper lip was checked using a cotton test for touch sensation, a pinprick test using a needle for sharp pain and a blunt instrument for testing pressure. Additionally, a two-point discrimination test was executed on the lip. The results were recorded on a score that ranges between 0 and 9, with 9 being the worst neurological score. The neurological score was assessed at 5 points in time: before surgery (T0), on the 1st (T1), the 7nd (T2), the 28th (T3), and the 90th (T4) postoperative day
patient satisfaction:Each patient was asked to complete a questionnaire on the 10th postoperative day subjectively rating their comfort and satisfaction with the applied postoperative cooling therapy. The grading scale ranged from 1 to 4, where 1 denoted “very satisfied” and 4 for “not satisfied”.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/01/12
  •   42
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

unilateral zygomatic bone fracture

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Exclusion Criteria

missing operability, foreseeable missing opportunity for follow-up examination, pregnancy, nursing, drug addiction, recent operations, and diseases of heart, metabolism, CNS, infectious, circulation, systemic, malignant and immune system affecting diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals and antibiotics

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Addresses

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    • Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Majeed  Rana 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Majeed  Rana 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Majeed  Rana 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover
    • Mr.  Dr. Dr.  Majeed  Rana 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/10/30
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Trial Publications, Results and other Documents

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