Swelling
Conditions
Keywords
orthognathic surgery, steroid, swelling, 3-dimensional photogrammetry
Brief summary
Postoperative swelling is one of most common concerns to plastic and oromaxillary surgeons after orthognathic surgery. The purpose of this study is to develop a steroid regimen protocol for minimizing postoperative facial swelling after orthognathic surgery.
Detailed description
Postoperative swelling is an annoying problem after orthognathic surgery. There are two reasons to minimize postoperative swelling. The first is a functional consideration. Orthognathic surgery is performed in oromaxillary area, and consequently swelling in this area can compromise airway. The second is esthetic one, as patients feel uncomfortable and embarrassing with a swollen face. Reducing facial swelling after orthognathic surgery helps to reduce airway complication and patient down time. Several methods are used to reduce postoperative facial swelling, including controlled hypotension during operation, meticulous operative procedures, postoperative facial ice packing, head elevation, and suction drainage. Perioperative use of steroid has been applied for reduction of facial swelling after oral surgery and 3rd molar extraction. Cyclooxygenase-1 (COX1) and COX2 have been reported to be important enzymes for inflammatory process, and steroids inhibit their synthesis, consequently reducing postoperative edema. Steroid has also been used to decrease edema after orthognathic surgery, as well as to reduce pain, nausea and vomiting. There were three randomized controlled studies looking at the effect of steroid on postoperative facial swelling after orthognathic surgery, separately by Dr. Weber et al, Peillon et al, and Munro et al. However, the results were controversial. The first two studies concluded that the steroid use could reduce facial swelling. The other one did not find significant difference between the experimental and control groups. Another limitation of the previous studies was that they all used two-dimensional or non-objective methods for evaluation of the amount of swelling, which could be less accurate. Three-dimensional photogrammetry has been introduced in recent years, and has obtained satisfactory results over the conventional methods. The investigators have experience of applying the device for facial surface study, and the accuracy has been validated in our imaging laboratory. The purpose of this study is to determine the effect of steroid for reduction of postoperative facial swelling determined by three-dimensional photographic method. 3dMD face scanner will be used. The 3-dimensional method makes no harm to patients. Patients will be seated during scanning and thus reducing possible inconvenience. There is no radiation hazard with this method. The image acquisition time is 2 milliseconds or less, and therefore no concern of motion artifacts. The first part of this study is to get information about the swelling curve after orthognathic surgery. 3dMD face scanning will be performed 5 times postoperatively every 12 hours after 24 hours of operation. When the postoperative timing of maximal facial swelling is obtained, the investigators will proceed to perform the second part of study, and the number of facial scanning is reduced. The second part of study involves recruiting 70 patients with prognathism. The patients will be carefully screened and selected by craniofacial surgeons. The patients will take preoperative and postoperative 3dMD image scanning. The recovery course and clinical outcome will be monitored. 3dMD face image data analysis will be performed for quantitative comparisons between the experimental and control groups.
Interventions
5mg
15 mg
Sponsors
Study design
Eligibility
Inclusion criteria
* patients who receive LeFort I osteotomy of maxilla and bilateral sagittal split osteotomy of mandible
Exclusion criteria
* patients with local or systemic diseases * patients taking aspirin, steroid, nonsteroidal anti-inflammatory drugs, or having contraindications for steroids * patients with history of psychosis * patients with active or chronic infection * patients with active or latent peptic ulcer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery | 1 year | Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DexamethasoneHigh-dose 15mg
Dexamethasonehigh-dose : 15 mg | 31 |
| DexamethasoneLow-dose 5mg
Dexamethasonelow-dose : 5mg | 25 |
| Total | 56 |
Baseline characteristics
| Characteristic | DexamethasoneLow-dose | DexamethasoneHigh-dose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 30 Participants | 50 Participants |
| Age, Continuous | 20.92 years STANDARD_DEVIATION 4.79 | 23.16 years STANDARD_DEVIATION 4.19 | 22.16 years STANDARD_DEVIATION 4.6 |
| Region of Enrollment Taiwan | 25 participants | 31 participants | 56 participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 31 |
| serious Total, serious adverse events | 0 / 25 | 0 / 31 |
Outcome results
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery
Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DexamethasoneHigh-dose | Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery | 36 hours postoperatively | 167.06 ml | Standard Deviation 55.93 |
| DexamethasoneHigh-dose | Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery | 1week postoperatively | 61.39 ml | Standard Deviation 30.14 |
| DexamethasoneHigh-dose | Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery | 1month postoperatively | 29.85 ml | Standard Deviation 19.4 |
| DexamethasoneLow-dose | Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery | 36 hours postoperatively | 190.73 ml | Standard Deviation 78.74 |
| DexamethasoneLow-dose | Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery | 1week postoperatively | 57.62 ml | Standard Deviation 36.13 |
| DexamethasoneLow-dose | Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery | 1month postoperatively | 19.34 ml | Standard Deviation 16.56 |