Plain English Summary
Background and study aims
Bruising and swelling are commonly associated with rhinoplasty (nose reshaping) and are the main factors that limit the return to daily activities. Several methods have been evaluated to minimize this, including the creation of subperiosteal tunnels, which involves raising the superficial vascular layer off the bone, preserving it from trauma during surgery. Our aim is to assess the efficacy of subperiosteal tunnels during rhinoplasty at reducing postoperative bruising and swelling.
Who can participate?
Men and women aged 17 years or older undergoing aesthetic rhinoplasty requiring bilateral osteotomies (cuts to the bony framework of the nose will need to be performed during surgery on both sides)
What does the study involve?
All patients will be undergoing rhinoplasty. They will be randomly allocated to have one side of their nose undergo subperiosteal tunnelling and one side to not (therefore all participants receive subperiosteal tunnelling, but the side that this will be done on is randomly assigned). 2 and 7 days post-surgery, bruising and swelling on each side of the nose will be assessed
What are the possible benefits and risks of participating?
Though the creation of subperiosteal tunnelling is widely performed, there is not much data on whether or not there is a reduction on bruising and swelling. The possible benefits could include less bruising/swelling post operatively on the side of the tunnelling . There are no added risks of surgery for participating subjects/
Where is the study run from?
Montreal Centre for Facial Plastic Surgery (Canada)
When is the study starting and how long is it expected to run for?
February 2015 to February 2017
Who is funding the study?
This study was investigator initiated and funded
Who is the main contact?
Dr Mark Samaha
mark.samaha@mcgill.ca
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPT
Study information
Scientific title
Postoperative ecchymosis and edema following subperiosteal tunnels in rhinoplasty: a blinded randomised clinical trial
Acronym
Study hypothesis
To assess the efficacy of subperiosteal tunnels prior to lateral osteotomies during rhinoplasty at reducing postoperative ecchymosis and edema.
Ethics approval
McGill University Faculty of Medicine Institutional Review Board, 10/05/2015, IRB Review Number A00-M17-15A
Study design
Interventional prospective single-centre matched-paired randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Post-operative ecchymosis and edema in rhinoplasty
Intervention
Subjects were randomly assigned to undergo subperiosteal tunneling on one side of the nose during rhinoplasty. The other side of the nose underwent rhinoplasty without the creation of tunnels. The randomisation process was done using Siri®, the voice activated virtual assistant on an Apple iPhone®, at the time of surgery. Siri® was asked to randomly select a number. If an even number was generated, the patient would undergo creation of subperiosteal tunnels prior to osteotomy in rhinoplasty on the right side. Patients were blinded to the side of the subperiosteal tunnels. Post operatively, 3 blinded evaluators were asked to grade the degree of ecchymosis and edema on each side of the face.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
The following are graded on a 0-10 visual analogue scale (VAS) 2 and 7 days after surgery:
1. Ecchymosis
2. Edema
Secondary outcome measures
N/A
Overall trial start date
01/02/2015
Overall trial end date
01/02/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 17 years or older
2. Aesthetic rhinoplasty requiring bilateral osteotomies
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
34
Participant exclusion criteria
1. Rhinoplasty without ostetomies
2. Rhinoplasty with unilateral or intermediate osteotomy
3. Not willing to provide informed consent
4. 7 day follow-up not possible due to scheduling conflicts
Recruitment start date
01/04/2015
Recruitment end date
30/08/2015
Locations
Countries of recruitment
Canada
Trial participating centre
Montreal Centre for Facial Plastic Surgery
1240 Beaumont, Suite 200
Montreal
H3P 3E5
Canada
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish in JAMA Facial Plastics
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Dr Mark Samaha (mark.samaha@mcgill.ca). Data will be available after publication, from approximately 01/01/2019 until 10/05/2022. The raw data included will be the grading of each participant on ecchymosis and edema by the evaluators on post-operative days 2 and 7. Access will be granted to researchers or institutions that could use our data for further evaluation of this surgical technique, for example for meta-analysis or a systematic review. Access will be granted by the PI (Dr Mark Samaha) upon request. Data will be anonymised by a numerical code and no patient identifiers will be used. Written consent has been obtained from the patients. There are no ethical or legal restrictions.
Intention to publish date
30/11/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30589927