Condition category
Surgery
Date applied
01/10/2018
Date assigned
01/10/2018
Last edited
01/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Mark Samaha

ORCID ID

Contact details

1001 Decarie Boulevard.
Quebec Canada
Department of Otolaryngology – Head & Neck Surgery
Division of Facial Plastic and Reconstructive Surgery
McGill University
Montreal
H4A 3J1
Canada

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

Sponsor information

Organisation

McGill University - Department of Otolaryngology Head & Neck Surgery, Division of Facial Plastic and Reconstructive Surgery

Sponsor details

1001 Decarie Boulevard. Montreal
Quebec
Canada
Montreal
H4A 3J1
Canada

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes