Transplantation capillaire / Omnigraft ® / Étude clinique

Five years of experience in micro and mini-grafting with the Omnigraft

By Marc Divaris, MD, Plastic Surgeon Clinic director in Paris Hospitals Associate professor of the stomatological and Maxillo-facial surgery at Salpétrière Hospital (Paris) Founding member and director of the french college of scalp surgery (Pierre and Marie Curie university) and Kevin Muiderman ,MD, Plastic surgeon (USA)

 

PRINCIPLE

The principle of this device was invented in France in 93 and since then medicamat has developed and upgraded the tools. The machine patented worlwide ( 2 different patents) has got the CE mark and the FDA 510K.

It is an electro-pneumatic device which can be used in various techniques of punches or strips. It is composed mainly of three types of instruments :

- A hollow shafted micro-motor to punch the bald skin or to take out the grafts in the donor site. The grafts will be automatically aspirated in a flask.
- 1 or 2 implanting hand-pieces for sucking the grafts by vacuum and inserting them in their recipient site by pressure through a piston meaning no touch, no squeezing
- A special dermatome called the Hairtome® with ready made kits of spacers and blades are available in different sizes. By mean of an important pneumatic pressure applied on the cover of the Hairtome the strips will be cut in well calibrated micro and mini-grafts. Up to 500 grafts can be cut at a time in a few minutes. On the new model ,all the tools are autoclavable, all necessary sizes of implanting heads,punches and ready made kits are available and a second implanting hand-piece has been added to the system to save time during implantation.

 

METHOD

A - The direct technique is at the origin of the development of this device.

It requires two operators, the patient is in a semi-seated position. After shaving the donor site and performed the anesthesia and infiltration the take out hand-piece is connected directly to the implanting hand-piece. The graft is taken from the donor site,keeping the proper angle of hair growth,suctionned into place into the implanting hand-piece before being placed by pressure through a piston into the recipient site.This technique less surgical than the strip technique is very well accepted by the patient but requires a good understanding between the two operators. Scarring is quite good for punches smaller than 1.5 mm but it requires a very precise angulation.

B - The semi-direct technique is similar to the direct technique but can be performed alone and requires less ability.

The grafts, thanks to the hollow shafted micro-motor are suctionned into the mini-flask, then placed on a gauze and the surgeon ( and/or the assistant) will place them in their recipient site using the implanting hand-pieces . The main advantages are indeed the simplicity of the technique and I think that these two techniques may have a certain success for small sessions, for patients afraid of surgery etc.
I have however little experience on this technique and I have always used the Omnigraft® with the strip technique in the present study.

 

PATIENTS AND METHOD

The present study has been realized with the Omnigraft® and the previous model (Medicamat : France) on a panel of 237 patients over the last five years.

198 men and 39 women ,age ranging from 19 to 74 years old.
No other technique than mini and micro-grafting were performed on these patients
The surgeries were always realized by myself and one assistant only.
I usually place the grafts with my assistant but indeed two assistants could do the implantation thus saving time for the surgeon.
The technique used was only the strip technique eventhough I have also realized few direct or rather semi-direct technique by punches with the Omnigraft®.
In 98% of the cases I have taken 5 strips with a multi blade scalpel.
The average lenght of the strips was 21 cm and average spacers were3 strips of 125mm and 2 of 2 mm.
All strips were cut with the Hairtome®, only in exceptional cases was I obliged to cut by hand few follicular units to break the frontal line due to very poor density of donor site.
I have used only the 1 and 1.5 mm ready made kits on the Hairtome®.
I have used in most of the cases the 1.2 and 1.5 mm implanting heads.
In only 9% of the cases I was obliged to use the 2 mm implanting head.
Average quality of grafts was :
Strip of 1.25 mm / Hairtome 1mm= 1 to 2 bulbs
Strip of 1.5 mm / hairtome 1 mm = 1 to 3
Strip of 1.5 mm / hairtome 1.5 mm = 3 to 5

Patients have been seen at D 1 for removing bangage and control of placement
At D 8 or 12 to take out the stiches or staples.
At 4 month (80% of the patients) for a control of the growth
62 patients had a second session
Having performed for many years the manual technique, I was able to compare in terms of quality the automation of the strip technique

 

THE HARVESTING

The incision with the multi blade knife is indeeed similar whether manual or with the Omnigraft®.It is the esential part of the surgery as far as the quality of the grafts are concerned. "If you get good strips, you get good grafts " With some experience the multi blade knife is a safe, rapid and reproductable method.
It is essential to do this gesture at a medium speed, with a regular pressure with non-coated blades ( no teflon) but instead usual n° 15 like Swann-Norton. I have noticed that the teflon coated blades cut better… the bulbs and with normal blades the bulbs shift from either side … at medium speed.

 

THE PREPARATION OF THE GRAFTS.

A real revolution thanks to the hairtome® :
Indeed after only few surgeries I was convinced by the very good quality of the grafts obtained witht the Hairtome®. The ready made kits permits to load the Hairtome in seconds compared to loading one by one the spacers and blades.
Eventhough these kits are reusable (maximum 4 times) and can be sterilized in an autoclave I do not take the risk of damaging a percentage of graft and throw them away after each surgery.
I started lately however to validate the quality of the grafts by a systematic control.
On four patients I have taken five strips which gave an average of 506 grafts each.
And I have first counted on the strip themselves the percentage rate of transection.
Having noted the transection on the strip, I have placed the grafts one by one under the microscope and with my assistanty we have counted the transected bulbs.
On 2025 grafts, we got 48 transections , meaning roughly a 2% rate.
This relatively low rate of transection is explained by following a very strict protocol;
Good placement of the strips
Good placement of the two different kind of silicone
And last but not least thanks to the uniform and progressive pressure applied to the metal lid under the pneumatic Hairtomer.Vertical pressure and very progressive penetration of the blades through silicones seems to be the genius part of this most useful tool of the Omnigraft®.
There is a lot of small tricks to get perfects calibrated grafts whether micro or mini's.
The preparation of the strips on the Hairtome : cleaning, trimming the fat, preparing the Hairtome, installing the strips properly, cutting them under the pneumatic press is performed by my assistant while I am preparing the recipient site.

 

PREPARATION OF RECIPIENT SITE

The preparation is done with the hollow shafted micro-motor which have numerous advantages compared to a normal motor.
Thanks to the vacuum, the bald skin is aspirated in a mini-flask, leaving a very clean hole and saving the time necessary to cut and sweep the debris.
One important plus is also the variety of sizes ranging from 1 mm to 1.9 mm 1 mm is used for front line, 1.2 or 1.3 are used for micro and 1.4 or 1.6 are used for mini grafts. The 1.9 mm is used mainly for density.
4 years ago, I was tempted to use slits more and more and accordingly I had developped a special needle affixed on the implanting hand-piece of the Omnigraft in order to avoid the preparation of the recipient site.The bevelled needle was penetrating the skin through the pointed end leaving no skin residue. This bevelled needle on the implantation tool was roughly similar in action to the Choi implantor but the loading was very easy thanks to the vacuum. Today however I have almost abandoned this technique and I went back to punching even for the front line with the 1 mm punches.There is for that many reasons. Less pressure during insertion, bald area or scar tissue can be removed, very good scarring with micro-punches, and morst important a much better and much precise direction of the hair growth.
I have noticed a much better angulation and more natural, more density which is necessary in many cases , less foliculitis and less trauma to the graft during insertion.

 

GRAFT PLACEMENT

The two blue implanting hand-pieces are also an important part of the Omnigraft.
The graft placement was indeed the most tedious part in the micro-grafting surgery.
When all the grafts are removed from the Hairtome, my assistant place them on a gauze
And I usually keep 20 to 30 grafts on this gauze placed on the glove of my left hand keeping in between my fingers a forceps to help avoid poping while inserting the graft with the implantor.
All the grafts being aligned on my glove I can choose the one needed and I suck it hair first and push it in the recipient site .It is important to get a minimum pressure and the graft must be pushed gently in its receiving site.
Thanks to the new model having two handpieces we can insert with my assistant our 500 grafts in about ½ hour.
The Omnigraft can also be used for implantation with the use of a catheter. The assistant pushing one by one a graft into the catheter, the graft arrives almost instantly in the implanting hand-piece. I have abandoned this technique as there were sometime clogging in the tubings and there was no real control of the quality of the graft except through the polycarbonate head of the implantor.Thanks to the second hand-piece the assistant double the speed of inserting the grafts.
With experience it is really possible to insert a graft every 3-4 second.
Compared to forceps there is no pressure (less poping) , less manipulation, "no touch ", easy to learn and fast.

 

CONCLUSION

I was convinced from the very beginning of the advantages of automation
It was also obvious with the first model that the device was requiring the understanding of quite a bit of tricks and good training.The operator was to be thoroughly familiar with the machine during any of the procedure. The present Omnigraft with integrated pneumatic hairtome, the two implanting hand-pieces, the new sizes of punches and heads, the ready made kits for the hairtome etc… has got a lot of improvements.
And, of course, if the results are comparable to that of manual techniques, it enables to save time, to reduce the personnel and to avoid sometime the tediousness and even headaches or hair transplant when you cannot afford to have a team of assistant working with you.