VITILIGO

Giovanni Menchini, MD

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.

PROCEDURE:

A. Prepare the patient:

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 will be extracted from the mastoid hairy area, containing hair follicle melanocytes.

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 in sterile conditions.

C. Prepare yourself:

I) Good light.

II) Goggles (optional).

III) Sterile gloves (personal choice).

NOW YOU ARE USING STERILE GLOVES! STERILE CONDITIONS AND SURGICAL BEHAVIOR FROM NOW ON!

D. Biopsy retrieval:

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

II) Disinfect the retrieval area with the antiseptic solution of your choice.

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

IV) Shave gently to remove the corneal epithelium.

V) Extract the samples with a 4 mm diameter dermal punch, the procedure will require 3 samples.

NOTE: 4 samples are required for an area of 100cm².

Using 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 to 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 rack under the rotor

NOTE: avoid placing the sample over the rotor.

II) Add 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 machine adaptor, that could be sterilized if needed.

IV) Place it in the Rigenera® machine rail into the main body and couple it with the machine rotor. Use the machine lateral button to shift the 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) Collect the micrograft solution through the specific connector of the Rigeneracons®.

VII) Avoid using a non-Luer Lock® syringe.

VIII) Increase the volume with sterile injectable physiologic solution.

NOTE: From the extraction of the micrograft to its processing and application, it should not take more than 30 minutes to maintain a cell viability >92%.

G. Application

I) The injection will be made with 30G1/2 needle using the intradermal superficial mesotherapy technique, which creates papules throughout the hypo-pigmentated area.

II) Injections of 0,1ml each cm2.

III) Phototherapy 3 times/week for 6 months after the procedure with UVB.

CLINICAL EXAMPLE FOR RATIO AREA/INJECTION TO INCREASE THE VOLUME:

Volume are to treat is 100cm²the injections should be 0,1ml per 1cm2.

Total number of injections will be: 100cm2*1cm2= 100 injection.

Total volume of the solution will be: 100 Injections * 0,1ml = 10ml.

Dilute the micrografts with sterile saline solution until you obtain 10ml.

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 for the first 48 hours: sport, yoga, sauna, etc.

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