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Bichectomy: Hydrodissection Technique

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ClinicalTrials.gov Identifier: NCT03554499
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
LUIS VALENCIA, Hospital General Dr. Ruben Leñero

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aging Procedure: Bichectomy with hydrodissection Procedure: Bichectomy Not Applicable

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.
  2. 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.
  3. Exclusion criteria : Patients with previous facial procedures, malar hypoplasia, obesity, metabolic diseases, coagulopathies or neuropathy diagnosis confirmed by a neurologist.
  4. Patient Sample : Total of 54 patients were included.
  5. 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.

  6. 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.

  7. Postoperative care was standardized and patients were followed up for at least 6 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bichectomy: Hydrodissection Technique
Actual Study Start Date : April 2, 2016
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : April 28, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydrodissection
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
Intraoral removal of buccal fat pads using hydrodissection technique
Other Name: Bichatectomy
Active Comparator: Control
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
Intraoral removal of buccal fat pads using conventional technique
Other Name: Bichatectomy


Outcome Measures
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Primary Outcome Measures :
  1. TRANSOPERATIVE PAIN [ Time Frame: 1 DAY ]
    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)

  2. 2 HOURS POSTOPERATIVE PAIN [ Time Frame: 1 DAY ]
    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. MAXIMUM PAIN IN FIRST 72 HOURS POSTOPERATIVE. [ Time Frame: 3 DAYS ]
    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)


Secondary Outcome Measures :
  1. SURGICAL TIME [ Time Frame: DURING PROCEDURE ]
    PROCEDURE TIME IN MINUTES SINCE THE FIRST INCISION TO THE END OF THE PROCEDURE

  2. BLEEDING [ Time Frame: DURING PROCEDURE ]
    1GAUZE = 5ML

  3. COMPLICATIONS [ Time Frame: 90 DAYS ]
    COMPLICIATIONS PRESENTED AFTER PROCEDURE


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with previous facial procedures, malar hypoplasia, obesity, metabolic diseases, coagulopathies or neuropathy diagnosis confirmed by a neurologist
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
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
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

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Responsible Party: LUIS VALENCIA, PLASTIC SURGERY RESIDENT, Hospital General Dr. Ruben Leñero
ClinicalTrials.gov Identifier: NCT03554499    
Other Study ID Numbers: 2050100617
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LUIS VALENCIA, Hospital General Dr. Ruben Leñero:
Facial aging
Buccal fat pad