Clinical trial NCT03554499: Bichectomy: Hydrodissection Technique
Official title: Bichectomy: Hydrodissection Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Facial aging
Buccal fat pad
Lead sponsor: Hospital General Dr. Ruben Leñero
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: TRANSOPERATIVE PAIN
timeFrame: 1 DAY
measure: 2 HOURS POSTOPERATIVE PAIN
timeFrame: 1 DAY
measure: MAXIMUM PAIN IN FIRST 72 HOURS POSTOPERATIVE.
timeFrame: 3 DAYS
Secondary outcomes:
measure: SURGICAL TIME
timeFrame: DURING PROCEDURE
measure: BLEEDING
timeFrame: DURING PROCEDURE
measure: COMPLICATIONS
timeFrame: 90 DAYS
Other outcomes:
Locations:
Study officials:
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