Effect of Steroid for the Postoperative Swelling After Orthognathic Surgery

February 6, 2014 updated by: Chang Gung Memorial Hospital

The Effect of Steroid on Reducing Facial Swelling After Orthognathic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone"low-dose"
5mg
Drug: Dexamethasone"low-dose"
5mg
Other Names:
  • dexan
Experimental: Dexamethasone"high-dose"
15mg
Drug: Dexamethasone"high-dose"
15 mg
Other Names:
  • dexan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Lun-Jou Lo, MD, Chang Gung Memorial Hospital
  • Study Chair: Hye-Young Kim, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 28, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 9, 2011

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-2811-B-182A-003
  • CGMH-IRB-100-2191B (Registry Identifier: CGMH IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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