SKIN REJUVENATION

Franco Perego, MD Plastic Surgery – Monza (Italy) Adjunct Professor School of Plastic and Reconstructive Surgery University of Padova (Italy)

This protocol supports Dermatologist, Plastic surgeon and Aesthetic Doctors in using Dermis Micrografts to improve the skin texture by modulating the inflammatory and regenerative processes.

Patient Selection

• For the first noticeable signs of skin aging / to prevent skin aging of the face and neck.

• Indicated for the relaxation / elastosis in “difficult” regions such as the lower third of the face, neck and décolleté.

• In association with fractional or ablative laser treatments, in order to enhance the induced regenerative effect, also modulating the inflammatory response of the laser and reducing its invasiveness.

• In association with Micro-needling treatments, in order to enhance the induced regenerative effect.

• To treat post-acne and post-surgical scars.

• For the preparation and maintenance of cervico-facial face-lifting operations, especially in the areas more predisposed to the relapse with hypo-elasticity of the skin (such as the neck and the sub-mental region).

• In association with lipofilling of the face, with the aim of enriching the adipose tissue.

PRE-PROCEDURE CONSIDERATIONS:

Clinical record is mandatory in accordance to local laws and requirements, although this is a minimally invasive medical procedure. Signed consent is required, like in any other aesthetic medicine procedure. Its characteristics will be subjected to the local laws. Thus, it is important that the physician is acquainted with them.

Pictures must follow a previous stablished guideline. Light, distance to focus, zoom, and camera from the pre-treatment photo must be the same for all the follow-up photo(s), so they can be compared.

REQUIRED EQUIPMENT:

• Rigenera Machine N4SA

• RIGENERACONS

• Surgical drapes and sterile gloves

• Chlorhexidine solution

• Sterile dressings

• Biopsy punch (2,5/3 mm diameter)

PROCEDURE:

A. Prepare the patient:

• Scalpel n° 15

• Lidocaine 2% without vasoconstrictor

• Luer lock Syringe of 1.0 ml for mesotherapy

• Needle 30/32 G

• NaCl solution

• Anatomical clamp and scissors

I) Protect the surgical field. Although this is an ambulatory procedure and, could be performed outside an operating room, sterile handling of the sample must be guaranteed at all times.

II) Micrograft can be extracted from the mastoid hairless area (close to the pre-hairline), behind the earlobe, or using the excess skin removed during a facial surgical procedure.

B. Prepare the equipment

I) Machine Rigenera®: The machine must be plugged-in to the electrical power source. Turn it on. Be sure that the engine lever is up.

II) Rigeneracons® device: Peel the protective shield and discard it. Only the Rigeneracons® device, inside the second cover, is sterile.

III) Disposable material: Leave it on an accessory table. The whole set must be ready-to-use and kept sterile.

C. Prepare yourself:

I) Good light.

II) Goggles (optional).

III) Sterile gloves (personal choice).

D. Biopsy retrieval:

I) Mark retrieval area, using a standard dermis marker.

II) Skin samples are performed in the area without hair follicles, back-auricular, mastoid or in other concealable regions (folds, furrows or areas of ongoing cutaneous removals during surgical procedures on the face).

III) Disinfect the retrieval area with the antiseptic solution of your choice (e.g.: Chlorhexidine).

IV) Anesthesia application in the periphery area without embedding the donor tissue (e.g.: 2% lidocaine without vasoconstrictor).

V) Shave gently to remove the stratum corneum with a scalpel n.15. -

VI) with a 2.5 / 3.0 mm punch, collect the full thickness skin samples.

Normally, the procedure will require:

• 3 Samples for face

• 4/6 samples for Face + Neck

• 6/7 samples for Face + Neck + Hands

NOTE: Using a 3- or 4-mm diameter dermal punches might require stitches.

E. Sample procurement:

The procedure is standard and extremely simple. A couple of setbacks, related with the small size of the sample, are relatively frequent:

• The tissue might stay inside the incision covered with blood.

• The tissue might stay inside the dermatome (dermal punch).

• It could be extracted with a needle.

• The tissue might get washed away by the blood.

• Mechanical compression is enough as hemostatic technique.

• Exceptionally, a stitch might be required.

F. Sample processing and micrograft solution generation:

I) Place the biopsies inside the Rigeneracons® device, over the hollowed disc under the rotor.

NOTE: Disaggregate maximum 3 skin samples at the time, since you have more add the remaining samples following the same procedure here described.

II) Add exactly 1.5 ml sterile injectable physiologic solution through the specific connector of the Rigeneracons® with a non-Luer Lock® syringe.

NOTE: Sample must slightly embedded, not submerged in it.

III) Close the Rigeneracon® and place it in the Sicurlid, that could be sterilized if needed, couple the device with the Sicurstik.

IV) Place it in the Rigenera® N4SA machine rail into the main body and couple it with the machine rotor.

V) Press the central button located in the machine front. For this specific protocol the sample should be disaggregated for 2 minutes, each pulse lasts 1 minute (1minute/pulse).

NOTE: A green led will indicate that the process has started. It is automatic and it lasts 2 minutes.

VI) After you have disaggregated all the samples needed, collect the micrografts through the specific hole of the Rigeneracons®. Avoid using non-Luer Lock® syringe.

VII) Dilute obtained Micrografts with sterile physiological solution, the dilution deepens on the area to treat:

• Face: 7.0 ml total solution = 140 injections

• Face + Neck: 15.0 ml total solution = 300 injections

• Face + Neck + Hands 22.0 ml total solution = 440 injections

MESOTHERAPIC INJECTION:

The mesotherapy treatment is performed with a 30/32 G needle, in the deep intra-dermal and superficial sub-dermal (depending on the thickness of the treated regions), with the clinical observation of a series of papules on the skin.

• Useful for this purpose to maintain an inclination of the needle of about 30-45 °.

• For a correct execution of the technique, it is necessary to use 1.0 ml luer-lock syringes with 0.05 ml injections, spaced 1.5 cm apart.

AFTER PROCEDURE CARE:

Hemostasis is achieved by mechanical compression. Normally, stitches are not needed. After the procedure, pictures must be taken under the same conditions from the preoperatory. Recommendations:

• Avoid activities that increase blood hydrostatic pressure he first 48 hours: sport, yoga, sauna, etc.

• Wound hygiene should be controlled. Sun protection is mandatory.