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Three-dimensional evaluation of postoperative swelling in treatment of zygomatic bone fractures using two different cooling therapy methods: a randomized, observer-blind, prospective study
© Modabber et al.; licensee BioMed Central Ltd. 2013
- Received: 13 March 2013
- Accepted: 19 July 2013
- Published: 29 July 2013
Surgical treatment and complications in 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, and hemorrhage, as well as the reduction of metabolism, bleeding and hematomas, have been described.
The aim of this study was to compare postoperative cooling therapy applied through the use of cooling compresses with the water-circulating cooling face mask manufactured by Hilotherm in terms of beneficial impact on postoperative facial swelling, pain, eye motility, diplopia, neurological complaints and patient satisfaction.
Forty-two 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 three-dimensional optical scanning technique. Furthermore, pain, neurological complaints, eye motility, diplopia and patient satisfaction were observed for each patient.
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.
Hilotherapy is more efficient in managing postoperative swelling and pain after treatment of unilateral zygomatic bone fractures than conventional cooling.
German Clinical Trials Register ID: DRKS00004846
- Zygomatic bone fracture
- Three-dimensional optical scanner
- Conventional cooling
The face represents the most prominent position in the human body and is often involved in trauma injuries. The zygomatic bone is particularly prone to facial injuries due to its prominence  and is the second most common mid-facial bone affected. The fracture of the zygomatic bone can pose considerable functional complications such as restricted mouth opening. Disruption of the zygomatic position can also carry psychological, aesthetic and functional significance, causing impairment of ocular and mandibular functions. Therefore, a prompt diagnosis of fracture and soft tissue injuries is important for both cosmetic and functional reasons .
In most cases the treatment of unilateral zygomatic bone fractures leads to a significant degree of tissue trauma that again causes an inflammatory reaction . As a result, patients display common postoperative symptoms and types of pain, facial swelling and functional impairment . Pain is typically brief and peaks in intensity in the early postoperative period. In contrast, facial swelling reaches the characteristic maximum 48 to 72 hours after surgery . These symptoms can affect the patient’s quality of life and well-being. To increase patient satisfaction after treatment of uni- and bilateral zygomatic bone fractures, it is a necessary goal to minimize side effects as much as possible . One way do so is to prescribe medication such as corticosteroids , non-steroidal anti-inflammatory drugs , a combination of corticosteroids and non-steroidal anti-inflammatory drugs  or enzyme preparations such as serrapeptase . Furthermore, there are also nonmedication methods to treat the above side effects. These can include manual lymph drainage , soft laser [12, 13] and cryotherapy . Historically, the therapeutic use of local or systemic cryotherapy was first described by Hippocrates . Beneficial effects of cold treatment on postoperative swelling have been described previously [16–20] as well as the positive impact on edema, pain and inflammation [21–23]. The activity of inflammatory enzymes rises with increasing temperatures . On reviewing the literature, there is a lack of scientific evidence and trials in oral and maxillofacial surgery which show positive as well as no effect of cold therapy . Cooling therapy varies from the conventional, such as ice packs, gel packs or cold compresses, to mechanically supported continuous cooling with face masks. Both positive and negative side effects have been previously discussed [16, 20]. The aim of this study was to examine the effect of hilotherapy in comparison with a conventional cooling method using cold compresses on swelling, pain, eye motility, diplopia, neurological complaints and overall patient satisfaction following treatment of unilateral zygomatic bone fractures.
The study was approved by the local ethics committee at the University Aachen, Germany (EK 142/2008). Before the beginning of the study, written informed consent was obtained from each patient.
Study protocol and inclusion criteria
Study inclusion and exclusion criteria
Unilateral zygomatic fracture
Complex midfacial fracture
Combination of infraorbital approach, eyebrow and buccal sulcus incision
Osteosynthesis using 2.0 mm and 1.5 mm plates (Stryker)
Plating along frontozygomatic suture, infraorbital margin and zygomatico maxillary buttress
Age between 18 and 79 years
Written informed consent
Potential to miss the follow-up examination
Heart, pulmonary, liver and kidney disease, chronic pain syndrome
Diseases affecting metabolism, central nervous system, infectious, circulation, systemic, malignant and immune system
Blood coagulation disorders
Allergic reactions to pharmaceuticals and antibiotics
Dermatological diseases of the face
During the study the following parameters were assessed: pain, swelling, eye motility, diplopia, neurological complaints and patient satisfaction. To minimize bias through patient contact, the patients were examined and hospitalized in separate rooms.
Measurement of facial swelling
Postoperative pain analysis was conducted with the help of a 10-point visual analogue scale based on measurements before surgery (T0), on day 1 (T1), day 2 (T2) and day 7 (T3) postoperatively, where the patients had to rate their pain on a score from 0 to 10, with 0 describing a situation without pain and 10 denoting a maximum intensity of pain.
The neurological analysis was utilized in order to enable the evaluation of nerve dysfunctions. The results were recorded on a score that ranges between 0 and 9, with 9 being the worst neurological score. The skin of the upper lip was checked using a cotton test for touch sensation (regular = 0; hypesthesia = 1; anesthesia = 2), a pinprick test using a needle for sharp pain (regular = 0; hypalgesia = 1; analgesia = 2), and a blunt instrument for testing sharp-blunt-discrimination (regular = 0; partly = 1; none = 2). Additionally, a two-point discrimination test (0 to 0.9 cm = 0; 1 to 2.5 cm = 1; 2.6 to 4 cm = 2; >4 cm = 3) was executed on the lip. The neurological score was assessed at five points in time: before surgery (T0), on day 1 (T1), day 7 (T2), day 28 (T3), and day 90 (T4) postoperatively.
Eye motility and diplopia
For the analysis of eye motility and diplopia the patient was required to fix on 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 four points in time: before surgery (T0), on day 1 (T1), day 7 (T2) and day 28 (T3) postoperatively.
Each patient was asked to complete a questionnaire on the postoperative day 10, 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 “not satisfied”.
To check for statistical significance of quantitative variables, the Student t-test for unrelated samples was used. All data are expressed as mean values ± standard deviation, with a P-value ≤0.05 taken as significant. For analyzing gender, eye motility and diplopia, a χ 2-test was utilized, and a P-value ≤ 0.05 was taken as a level of significance. The statistical analysis was conducted using SPSS for Windows version 14.0 (SPSS Inc., Chicago, IL, USA).
Baseline characteristics of patients
Female gender (n/total (%))
35.6 ± 21.9
Body mass index (kg/m2)
23.8 ± 3.6
24.4 ± 3.8
Surgery duration (minutes)
70.2 ± 33.4
73.9 ± 38.7
Hospitalization duration (days)
4.6 ± 1.9
4.4 ± 1.1
Preoperative pain score (visual analogue scale)
3.1 ± 0.7
3.2 ± 0.8
Preoperative neurological score
3.4 ± 1.7
3.5 ± 1.7
Preoperative limited eye motility (n/total (%))
Preoperative diplopia (n/total (%))
Postoperative pain score
Postoperative neurological score
Eye motility and diplopia
Using a χ 2-test, no statistically significant differences were found preoperatively between groups with respect to eye motility and diplopia (Table 2). On postoperative day 1, a significant reduction in eye motility limitation (Hilotherm, 17 patients without and 4 patients with limited eye motility versus conventional, 11 patients without and 10 patients with limited eye motility, P = 0.050) and diplopia (Hilotherm, 18 patients without and 3 patients with diplopia versus conventional, 11 patients without and 10 patients with diplopia, P = 0.019) was obtained through hilotherapy compared to conventional cooling. There were no statistically significant differences found between groups concerning the limitation of eye motility and diplopia 7 and 28 days after surgery (day 7, Hilotherm, 18 patients without and 3 patients with limited eye motility versus conventional, 15 patients without and 6 patients with limited eye motility, P = 0.259; Hilotherm, 19 patients without and 2 patients with diplopia versus conventional, 16 patients without and 5 patients with diplopia, P = 0.214; day 28, 19 patients without and 2 patients with limited eye motility in both groups, P = 1.000; 20 patients without and 1 patient with diplopia in both groups, P = 1.000).
This study demonstrates that continuous cooling with the hilotherapy device reduces postoperative swelling and pain in the treatment of unilateral zygomatic fractures compared to conventional cooling with cold packs. Furthermore, satisfaction of patients treated with hilotherapy was greater compared to patients who received conventional cooling. However, eye motility limitation, diplopia and neurological score revealed significant differences only at postoperative day 1. Wound healing was uneventful. Malfunctioning of the Hilotherm cooling device did not occur.
The healing process and possible complaints regarding the treatment of facial trauma can be influenced by patient-related factors such as age and gender, compliance and health status as well as patient independent factors such as surgeon experience, duration of surgery time, extent of trauma and fragment dislocation as well as use of antibiotics [3, 18, 19, 30]. Since in this study the use of antibiotics and the duration of surgery time were not significantly different among both groups, and since health-compromised patients were excluded from the study, these factors are considered not to have influenced the observed results.
Although the effects of different cooling methods have been investigated for a number of maxillofacial and plastic surgery treatment procedures, there is so far no study comparing conventional cooling versus hilotherapy following treatment of zygomatic bone fractures [18, 19, 31–33].
Consistent with our results, Belli and colleagues  reported the safe use of hilotherapy as well as a postoperative decrease in pain and swelling intensity and duration after Le-Fort-I osteotomy and bilateral sagittal osteotomy of the lower jaw. While they investigated only 10 patients without a comparison to other cooling techniques, Jones and colleagues  recorded differences between hilotherapy and conventional groups in a greater cohort of 50 patients following face-lift surgery procedures. In contrast to our results, Jones and colleagues  described a statistically significant increase in patient-reported postoperative swelling in the Hilotherm group with no significant differences regarding ecchymosis, hematoma or pain between groups. However, subjectively the majority of patients found the cooling masks to be comforting. In order to overcome the lack of significance of subjective assessments versus objective evaluation methods, Moro and colleagues  measured the distance of multiple anatomic landmarks for swelling purposes. In so doing, 90 patients operated on for maxillomandibular malformations were divided into three groups and treated either with hilotherapy, conventional cooling or left untreated as a control group. As expected, no cryotherapy treatment led to the worst results whereas cooling with the hilotherapy method showed the least degree of swelling.
With the aim of improving measurement accuracy of different swelling stages, our study group used three-dimensional evaluation by the means of an optical face scanner [18–20]. Hence, three-dimensional volumes could be measured instead of two-dimensional lines.
Although cryotherapy is a relatively safe way to treat complications after oral or maxillofacial surgeries, cold therapy should only be employed with caution. Above all, very young or very old patients can react with intolerances to external cooling .
Topographical considerations make it difficult to quantify the facial volume of swelling. However, there are some limitations of this measurement technique which have to be discussed. The volume measurement with this technique is limited to localized facial swelling, since facial areas which have not been affected by the swelling are necessary for surface matching [18, 19]. Some methods are described to predict soft tissue via cephalograms, which are able to create three-dimensional images. Ethically, the benefit of cephalograms might not justify the patient’s exposure to ionizing radiation .
In summary, use of the cooling device by Hilotherm reduces postoperative swelling and pain compared to conventional cooling. Biological effects of cooling therapy on vascular, neural, metabolic and muscular sites are known. Cryotherapy decelerates cell metabolism because, according to Van’t Hoff law, it slows down biochemical reactions. Regarding vascular effects, cold therapy constricts blood vessels. The intensity of vasoconstriction reaches the highest value at a temperature of 15°C. Furthermore, a decrease in body temperature slows down peripheral nerve conduction. For temperatures below 15°C, nerve conduction is completely disabled and the vasoconstriction turns into a vasodilatation. These biological effects influence postoperative symptoms. Meanwhile, the anti-edema effect is caused by the vasoconstriction and the pain reducing effect of the cold is related to a blocking of nerve endings. This blocking decelerates nerve conduction, and consequently the inflammation phenomena. Ice packs or similar conventional cooling methods use a temperature of around 0°C. Such a low temperature constrains lymph drainage and cell metabolism . The effects of a treatment with overly low temperatures have already been mentioned. The inference is that a system is needed that maintains the desired temperature over a fixed period of time. To fulfill this requirement, this study worked with the cooling device Hilotherm Clinic (Hilotherm GmbH) . Further studies are needed to investigate the benefits of this technique in other clinical research areas.
Hilotherm is easy to use for both, patients and medical staff. Constant cooling with the possibility of adjusting temperature are important advantages. This is why hilotherapy is expected to play a greater role in oral and maxillofacial surgery as well as other clinical fields in the future.
Approval for the study was obtained from the relevant ethics committee at the University of Aachen, Germany (EK 142/2008). Before the beginning of the study, written informed consent was obtained from each patient. The study was registered with the Trial Registration Number: DRKS00004846.
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