Bichectomy: Hydrodissection Technique

NCT03554499 | Completed

• 1 other identifier: 2050100617
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Aging

Keywords

Facial aging; Buccal fat pad

Outcome Measures

Primary Outcomes (3)

• 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)

  1 DAY

• 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)

  1 DAY

• 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)

  3 DAYS

Secondary Outcomes (3)

• SURGICAL TIME

  DURING PROCEDURE

• BLEEDING

  DURING PROCEDURE

• COMPLICATIONS

  90 DAYS

Study Arms (2)

Hydrodissection

EXPERIMENTAL

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.

Procedure: Bichectomy with hydrodissection

Control

ACTIVE COMPARATOR

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.

Procedure: Bichectomy

Interventions

Bichectomy with hydrodissection PROCEDURE

Intraoral removal of buccal fat pads using hydrodissection technique

Also known as: Bichatectomy

Hydrodissection

Bichectomy PROCEDURE

Intraoral removal of buccal fat pads using conventional technique

Also known as: Bichatectomy

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital General Dr. Ruben Leñero: lead

Related Publications (11)

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

  PMID: 19336124 BACKGROUND

• 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.

  PMID: 1952712 BACKGROUND

• 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.

  PMID: 24438602 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23417575 BACKGROUND

• 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.

  PMID: 19937328 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 2293733 BACKGROUND

• 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.

  PMID: 19338917 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PLASTIC SURGERY RESIDENT

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 13, 2018
• Study Start: April 2, 2016
• Primary Completion: October 31, 2017
• Study Completion: April 28, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06