Trial Outcomes & Findings for Effect of Steroid for the Postoperative Swelling After Orthognathic Surgery (NCT NCT01431014)

Last Updated: 2014-03-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

56 participants

Primary outcome timeframe

1 year

Results posted on

2014-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamethasone"High-dose" 15mg Dexamethasone"high-dose" : 15 mg	Dexamethasone"Low-dose" 5mg Dexamethasone"low-dose" : 5mg
Overall Study STARTED	34	34
Overall Study COMPLETED	31	25
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Steroid for the Postoperative Swelling After Orthognathic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone"High-dose" n=31 Participants 15mg Dexamethasone"high-dose" : 15 mg	Dexamethasone"Low-dose" n=25 Participants 5mg Dexamethasone"low-dose" : 5mg	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=99 Participants	20 Participants n=107 Participants	50 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	23.16 years STANDARD_DEVIATION 4.19 • n=99 Participants	20.92 years STANDARD_DEVIATION 4.79 • n=107 Participants	22.16 years STANDARD_DEVIATION 4.6 • n=206 Participants
Sex: Female, Male Female	15 Participants n=99 Participants	13 Participants n=107 Participants	28 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	12 Participants n=107 Participants	28 Participants n=206 Participants
Region of Enrollment Taiwan	31 participants n=99 Participants	25 participants n=107 Participants	56 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Dexamethasone"High-dose" n=31 Participants 15mg Dexamethasone"high-dose" : 15 mg	Dexamethasone"Low-dose" n=25 Participants 5mg Dexamethasone"low-dose" : 5 mg
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery 36 hours postoperatively	167.06 ml Standard Deviation 55.93	190.73 ml Standard Deviation 78.74
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery 1week postoperatively	61.39 ml Standard Deviation 30.14	57.62 ml Standard Deviation 36.13
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery 1month postoperatively	29.85 ml Standard Deviation 19.40	19.34 ml Standard Deviation 16.56

Adverse Events

Dexamethasone"Low-dose"

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone"High-dose"

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lun-Jou Lo, MD,Hye-Young Kim, MD

Chang Gung Memorial Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place