3D evaluation of postoperative swelling in treatment of zygomatic bone fractures using 2 different cooling therapy methods: - A randomized observer blind prospective study –
Organizational Data
- DRKS-ID:
- DRKS00004846
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2013-03-26
- Last update in DRKS:
- 2013-03-26
- Registration type:
- Retrospective
Acronym/abbreviation of the study
Cooling therapy in treatment of zygomatic fractures
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- S02.4 - Fracture of malar and maxillary bones
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 21 patients were treated with conventional cooling after reposition of unilateral zygomatic bone fractures
- Arm 2:
- 21 patients received continuous cooling using hilotherapy after reposition of unilateral zygomatic bone fractures
Endpoints
- 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”.
- Secondary outcome:
- No Entry
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Medizinische Hochschule Hannover Hannover
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2009-01-12
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2012-10-30
- Target Sample Size:
- 42
- Final Sample Size:
- 42
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- unilateral zygomatic bone fracture
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
Addresses
Primary Sponsor
- Address:
- Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und GesichtschirurgieDr. Dr. Majeed RanaCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +49-511-532-4716
- Fax:
- +49-511-532-4740
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und GesichtschirurgieDr. Dr. Majeed RanaCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +49-511-532-4716
- Fax:
- +49-511-532-4740
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und GesichtschirurgieDr. Dr. Majeed RanaCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +49-511-532-4716
- Fax:
- +49-511-532-4740
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und GesichtschirurgieDr. Dr. Majeed RanaCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +49-511-532-4716
- Fax:
- +49-511-532-4740
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Medizinische Hochschule HannoverCarl-Neuberg-Straße 130625 HannoverGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission an der Med. Fakultät der RWTH Aachen am Universitätsklinikum AachenPauwelsstr. 3052074 AachenGermany
- Telephone:
- +49-241-8089963
- Fax:
- +49-241-8082012
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2008-09-17
- Ethics committee number:
- CIS-EK 142/2008
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2008-10-05
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry