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AgingNCT03554499

Bichectomy: Hydrodissection Technique

A study testing Bichectomy with hydrodissection and Bichectomy in people with Aging, run by Hospital General Dr. Ruben Leñero.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Buccal Fat Pad provides volume to the middle third of the face and occasionally may cause deepening of the nasolabial fold and relaxation of the mimetic muscles, both associated with aging. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Bichectomy with hydrodissection and Bichectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
2 Apr 2016to 28 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult patients older than 18 years with a round face and prominent cheeks undergoing bichectomy to improve aesthetic facial contours

Who cannot join

  • Patients with previous facial procedures, malar hypoplasia, obesity, metabolic diseases, coagulopathies or neuropathy diagnosis confirmed by a neurologist

About this study

Buccal Fat Pad provides volume to the middle third of the face and occasionally may cause deepening of the nasolabial fold and relaxation of the mimetic muscles, both associated with aging. Bichectomy is the surgical procedure in which the buccal fat pad is remove in order to achieve a youthful and aesthetic appearance, getting harmony in facial contour. The purpose of this study was to compare the usual technique with an alternative method, using hydrodissection to facilitate the dissection of the Buccal Fat Pad making this procedure safer, efficient and more pleasant for the patient.

Read the detailed description

This is a randomized controlled trial primarily designed to compare an alternative method for Bichectomy using hydrodissection. All procedures were performed by the same surgeon using the same technique, the only difference was the infiltration methods.

  1. Two groups were assigned:
  • Group A - Bichectomy with hydrodissection = infiltration of 15ml per side of a special solution (250ml of saline 0.9% + 1mg of epinephrine + 20ml of 2% Lidocaine, equivalent to 0.0555mg of epinephrine and 22.2mg of Lidocaine per side), prior to the incision with the following distribution: 1ml in the form of a wheal in the oral mucosa with a 22G needle 1cm behind the Stenon canal opening that corresponds to the incision site and 14 ml on the virtual space where the buccal fat pad is located, which is immediately identified after penetrating the fascia of the buccinator muscle where you can feel a difference in resistance.
  • Group B - Bichectomy without hydrodissection = infiltration with 3ml per side of 2% Lidocaine with 1: 200,000 epinephrine ( equivalent to 0.015mg of epinephrine and 60mg of Lidocaine per side) at the operative site.
  1. Inclusion criteria : Adult patients older than 18 years old with a round face and prominent cheeks undergoing bichectomy to improve aesthetic facial contour during the period April 2016 and October 2017.
  2. Exclusion criteria : Patients with previous facial procedures, malar hypoplasia, obesity, metabolic diseases, coagulopathies or neuropathy diagnosis confirmed by a neurologist.
  3. Patient Sample : Total of 54 patients were included.
  4. Surgical technique: patient lay down at 30º angle, a 0.5cm incision of the mucosa with a 15 blade in a horizontal fashion placed 1cm posterior to stenon canal opening, then a Kelly clamp is introduce pushing towards the ear lobe until a resistance is passed which corresponds to the buccinator fascia, the Kelly clamp is opened following the buccinators muscle fibers direction and the fat pad is immediately identified, extracted, and leaving the wound open for closure by second intension.
  5. Variables analyzed: 6.1) Transoperative pain - Patients were provided with a validated visual analogue scale (VAS) for pain and asked to rate their pain in a range of 0-10 6.2) Postoperative pain at 2 hours - Patients were provided with a validated visual analogue scale (VAS) for pain and asked to rate their pain in a range of 0-10. 6.3) Maximum pain in first 72 hours postoperative - Patients were provided with a validated visual analogue scale (VAS) for pain and asked to rate their pain in a range of 0-10. 6.4) Procedure time - surgical time was quantified with a digital chronometer (IPhone 5s) managed by an independent operator, from the initial incision to the time of extraction for both fat pads. 6.5) Bleeding - was recorded by measuring total number of soaked gauze with each piece of gauze holding 5cc of blood. 6.6) Complications - complications were collected prospectively, defined as being within the first 90 postoperative days.
  6. Postoperative care was standardized and patients were followed up for at least 6 months.
Conditions
Aging
Being tested
Bichectomy with hydrodissection, Bichectomy
Keywords
Facial aging, Buccal fat pad

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bichectomy with hydrodissectionProcedure or surgery

    Also called Bichatectomy

    Intraoral removal of buccal fat pads using hydrodissection technique

  • BichectomyProcedure or surgery

    Also called Bichatectomy

    Intraoral removal of buccal fat pads using conventional technique

Study groups in NCT03554499
Study groupRoleWhat they receive
HydrodissectionExperimentalBichectomy with hydrodissection = infiltration of 15ml per side of a special solution (250ml of saline 0.9% + 1mg of epinephrine + 20ml of 2% Lidocaine, equivalent to 0.0555mg of epinephrine and 22.2mg of Lidocaine per side), prior to the incision with the following distribution: 1ml in the form of a wheal in the oral mucosa with a 22G needle 1cm behind the Stenon canal opening that corresponds to the incision site and 14 ml on the virtual space where the buccal fat pad is located.
Receives: Procedure: Bichectomy with hydrodissection
ControlActive comparatorBichectomy without hydrodissection = infiltration with 3ml per side of 2% Lidocaine with 1: 200,000 epinephrine ( equivalent to 0.015mg of epinephrine and 60mg of Lidocaine per side) at the operative site.
Receives: Procedure: Bichectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TRANSOPERATIVE PAIN

    INVESTIGATORS ASK THE PATIENTS TO RATE THEIR PAIN PERCEPTION USING THE VISUAL ANALOG SCALE FOR PAIN (VAS PAIN), USING A NUMERICAL RATING SCALE FROM 0 (NO PAIN) - 10 (SEVER PAIN)

    Measured: 1 DAY

  2. 2 HOURS POSTOPERATIVE PAIN

    INVESTIGATORS ASK THE PATIENTS TO RATE THEIR PAIN PERCEPTION USING THE VISUAL ANALOG SCALE FOR PAIN (VAS PAIN), USING A NUMERICAL RATING SCALE FROM 0 (NO PAIN) - 10 (SEVER PAIN)

    Measured: 1 DAY

  3. MAXIMUM PAIN IN FIRST 72 HOURS POSTOPERATIVE.

    INVESTIGATORS ASK THE PATIENTS TO RATE THEIR PAIN PERCEPTION USING THE VISUAL ANALOG SCALE FOR PAIN (VAS PAIN), USING A NUMERICAL RATING SCALE FROM 0 (NO PAIN) - 10 (SEVER PAIN)

    Measured: 3 DAYS

Secondary outcomes (3)

  1. SURGICAL TIME

    PROCEDURE TIME IN MINUTES SINCE THE FIRST INCISION TO THE END OF THE PROCEDURE

    Measured: DURING PROCEDURE

  2. BLEEDING

    1GAUZE = 5ML

    Measured: DURING PROCEDURE

  3. COMPLICATIONS

    COMPLICIATIONS PRESENTED AFTER PROCEDURE

    Measured: 90 DAYS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start2 Apr 2016
  3. Primary completion31 Oct 2017
  4. Study completion28 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03554499
Sponsor's protocol ID
2050100617
Status last verified
Jun 2018
First submitted
9 May 2018
Last updated
15 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jackson IT. Buccal fat pad removal. Aesthet Surg J. 2003 Nov-Dec;23(6):484-5. doi: 10.1016/j.asj.2003.08.005.

    PubMed 19336124

  • Matarasso A. Buccal fat pad excision: aesthetic improvement of the midface. Ann Plast Surg. 1991 May;26(5):413-8. doi: 10.1097/00000637-199105000-00001.

    PubMed 1952712

  • Khiabani K, Keyhan SO, Varedi P, Hemmat S, Razmdideh R, Hoseini E. Buccal fat pad lifting: an alternative open technique for malar augmentation. J Oral Maxillofac Surg. 2014 Feb;72(2):403.e1-15. doi: 10.1016/j.joms.2013.10.002. Epub 2013 Oct 16.

    PubMed 24438602

  • Eber Luis de L S. Bichectomy or Bichatectomy - A Small and Simple Intraoral Surgical Procedure with Great Facial Results. Adv Dent & Oral Health. 2015; 1(1): 555555. doi: 10.19080/ADOH.2015.01.555555

  • Xu J, Yu Y. A modified surgical method of lower-face recontouring. Aesthetic Plast Surg. 2013 Apr;37(2):216-21. doi: 10.1007/s00266-013-0080-x. Epub 2013 Feb 16.

    PubMed 23417575

  • Yousuf S, Tubbs RS, Wartmann CT, Kapos T, Cohen-Gadol AA, Loukas M. A review of the gross anatomy, functions, pathology, and clinical uses of the buccal fat pad. Surg Radiol Anat. 2010 Jun;32(5):427-36. doi: 10.1007/s00276-009-0596-6. Epub 2009 Nov 25.

    PubMed 19937328

  • Quispe GD, Lupa C. Cirugía estética de mejillas. Rev Act Clin Med 2014;48:2538-2541. ISSN 2304-3768.

  • Hasse FM, Lemperle G. Resection and augmentation of Bichat´s fat pad in facial contouring. Eur J Plast Surg. 1994;17:239-242. doi: 10.1007/BF00208838

  • Bayter JE. Manejo de líquidos, lidocaína y epinefrina en liposucción. Rev Colomb Anestesiol. 2015;43(1):95-100. doi:10.1016/j.rca.2014.09.007

  • Stuzin JM, Wagstrom L, Kawamoto HK, Baker TJ, Wolfe SA. The anatomy and clinical applications of the buccal fat pad. Plast Reconstr Surg. 1990 Jan;85(1):29-37. doi: 10.1097/00006534-199001000-00006.

    PubMed 2293733

  • Matarasso A. Managing the buccal fat pad. Aesthet Surg J. 2006 May-Jun;26(3):330-6. doi: 10.1016/j.asj.2006.03.009.

    PubMed 19338917

Questions about this trial

What is this clinical trial studying?

A study testing Bichectomy with hydrodissection and Bichectomy in people with Aging, run by Hospital General Dr. Ruben Leñero.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TRANSOPERATIVE PAIN (time frame: 1 DAY). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03554499, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.

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