Radiolase matrixectomy

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Just how many pods are using the radiolase for nail surgery and how successful is it

 

BEEN USING RADIOLASE FOR SOME TIME NOW WITH NO PROBLEMS AT ALL:

 

Has anyone got any data regarding rates of nail regrowth comparing radiolase and phenol?

 

I am about to do two audits (not research but audits) of two groups of 50 ops one using phenol and one radiolase. I will pick randomly with the only confines being that each group must have been seen at the same time of year.

I will post back when this is done.

 

Radiolase

Hi

I am about to carry out some research on radiolase and phenol, but can not find any information on radiolase, I would be very grateful if someone could point me in the right direction

Regards

Polly pod:dizzy:

 

Re: Radiolase

Polly have you read this thread ?

http://www.podiatry-arena.com/podiatry-forum/showthread.php?t=13587

 

About 2 years ago our department started using radiolase for nail surgery with the hope of progressing to use it for neurofibrous HD excision in the future. Unfortunately we found, following all the protocols to the letter that the unit didn't stand up to all the hype. We have had a more decreased success rate with more of the patient on whom the radiolase was used suffering regrowths. That wasn't the worst of it. We also had 2 patients, one of whom had high risk factures ie neuropathy that we weren't aware of at the time, and one of whom had no risks whatsoever, who after having radiolase used suffered major ulceration down to bone. Fortunately they both healed up but not before causing considerable concern. The radiolase unit now sits waiting for collection to have checked by the manufacturer.

 

Sorry if this sounds like an obvious question, but were the people who used the unit for nail surgery actually trained in it's use?

The ulceration down to the bone sounds as if the tissue was overheated with too much lateral heat spread. I do not own a unit myself but a friend of mine does.

 

All of the staff were trained in the use of the equipment and the probes were not left in contact with the tissue for more than the recommended time. One of the worst healers patient wise was on the first patient we used the equipment on, the patient was actually treated by the person training us in its use. He took over 6 months to heal. His however didn't go down to bone it was just an ulcerated mess for months. Although we did think that he may have had issues with not following dressing regime properly. However all the others followed the protocols to the letter. The machine is now waiting for testing, but in my eyes we've had too many regrowths compared to our original phenol use. All of the patients, except 1 or 2, have had regrowths, including one of the patients who actually ulcerated down to bone.

 

"All of the staff were trained in the use of the equipment and the probes were not left in contact with the tissue for more than the recommended time."

My friend (who is not on Pod Arena) wanders whether they had the intensity on too high!


"but in my eyes we've had too many regrowths compared to our original phenol use. All of the patients, except 1 or 2, have had regrowths, including one of the patients who actually ulcerated down to bone."

Have these been TNAs or PNAs please?

 

In my friend's opinion, you REALLY need to know what you are doing to use this machine for this purpose correctly.

She feels that you need to really do at least 5 PNAs and 5 TNAs under the supervision of someone who really knows the machine, to get it correct!

It's technique!

 

we had a full days training and the patients have had both PNA's and TNA's. We had the the settings set low if anything exactly the way we were trained and used it for the minimum amount of time in contact with the nail bed. I know another area has used radiolase for a lot longer than we did and when we had the problems I was given their number to speak to them and see if we'd done anything wrong. They said that they'd also had more ulcerations which were deeper than with phenol use but they said they were using it with good results. As we had the problems even with patients with supposedly low risks we decided discretion was the better part of valor. The unit has been shelved awaiting testing by both the manufacturer and the organisation that you report medical device problems to. If I ever hear the results of the tests I'll post them as soon as I get them. Until then good luck and I hope people using the machine don't come across the problems we encountered.

 

An interesting thread, as I`ve successfully used radio-surgery for over 20 years without any ill effects.

I`m interested in the terms used, such as 'in contact with tissues`, 'in contact with nail bed' and 'the tissue was overheated with too much lateral heat spread'.

The whole technique is not based on contact but on near contact so that a current arcs from the blade to the tissue. If you can feel contact then the technique is wrong and yes, the tissue will heat up. The procedure should last no longer than a few seconds.

When used for cutting, the loop should again barely touch the tissue, like gently brushing with a feather !

The wrong technique results in heating without immediate tissue destruction. I`ve even heard of radiolase used in conjunction with phenol, definite overkill !

 

the training we had informed us that the electrodes be in contact withe the tissue for no more than 10 seconds with only very light touch. The person demonstrating the machine even showed us on patients and we had to follow her example and treat patient with her watching our technique. we followed her example to the letter and she said whether our technique was correct or not. We never even got a chance to try the cutting loop. We can only go off the training we had and the comments of the demonstrator. If their technique was wrong then it would follow that so was ours. The manufacturer or supplier of the machine was also present during the learning presentation.
If their technique is flawed they should be stopped from the supplying and demonstrating of such potentially dangerous medical devices.

 

Exactly the same as the training I had.

I don't use the kit anymore favouring the tried and tested phenol.

 

the phenol is more reliable and is the old firm favorite of our department. Its still the method taught in the podiatry schools so as far as I'm concerned its the one I'll continue to use. Radiolase is one that I've seen and heard too many horror stories about. When we had the problems I was given the number of another podiatrist in another nhs trust who was still using the radiolase but they also gave me the same horror stories.

 

'the phenol is more reiable'

Yes of course it is if the radiolase technique is wrong.

My experience is as follows. For phenol matrixectomies the aim was for complete healing within 21 days, this should be achievable after experience is gained.

I started using an Ellman unit 20 years ago. I found it even more controllable than phenol, less messy, less painful and healing could be even quicker.

I've come across many disasters from both methods, usually over treatment.
If close contact is made with the blade, heating the tissues will destroy them; if the dermis is destroyed, healing is impossible. Properly used, heat is not generated in the tissues.

Who has been teaching the radiolase technique, have they been teaching their own mistakes ?

 

The person who taught it was a podiatrist who was now employed by the people who are selling the radiolase equipment. If their method is incorrect then they need to be stopped as we had 2 very near misses

 

Hi

I've been asked to look into radiolase as an alternative to Phenol and can only find companies in the US. Are there any in the UK? Also has anyone one got any recent info audit data etc as this tread started some time ago. I would appreciate any help.

Thanks

sarah

 

Hi All,

I am thinking of conducting some research into radiolase and comparing it with phenolic ablation of the nail matrix, after partial nail avulsion. I have been somewhat 'put off' however by the previous threads. Indeed, these mention the fact that there was ulceration down to bone, regardless of following recommended procedures, and that as a result, the units had been either shelved or sent for testing. The threads also state that when results of the testing are available, they will be posted. With this in mind, I am wondering whether the link I have just found, below, is the published result of the adverse event described and whether in fact, it was indeed as a result of improper application of the therapy?

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1211045

I would be very grateful of my senior colleagues' opinion as to the value of producing a paper comparing phenol with radiolase, given the apparent - and justified - favour in the above threads, towards phenolic ablation remaining as preferred practice. Can anyone advise me? I would be most grateful.

Kindest regards,

Koota.

 

The GUIDELINES that I have here say, Haemo 4-5 increasing to 7-8 if required.

Alternatively, Cut/Coag 4-5, should not need to go beyond 6.

I remove the nail, wipe the nail bed area with saline moistened sterile gauze. Then I VERY LIGHTLY, yes VERY LIGHTLY hover the probe over the nail bed area for a brief moment. This should cause a colour change in the nail bed. If there are other areas of nail bed to be done by the electrode, then I allow and COUNT IN FRONT OF PATIENT, 10s to allow any heat to dissipate, before applying the electrode to another area of the nail bed.

You must NOT have the electrode in FULL contact or you will cause dermal damage.

But, just in case anything gets legal, take a few seconds to write exact method in the notes, eg, "Radiolase haemo 4.5 1s, 10s gap, 4.5 1s. this would be for covering by electrode both the prox and dist parts of the sulci for a PNA,

or eg "Radiolase 4.5, 1s per area, 10s gap in between areas. for TNA

In the event of anything becoming legal, that 4.5 setting, 1s application, and 10s gap between applications, could save you from being sued.

 

regarding my threads, I'm not saying that the procedure we were taught by the people who supply the equipment was the correct procedure but we followed their instructions to the letter. The results were tissue damage to bone in 2 cases but more or less every other treatment for nail bed ablation resulted in regrowth. It seems from the post from Simon Ross we may have been taught incorrectly but we were not the only ones as when I contacted another department locally they have been ultimately more successful with regard to lack of regrowth but did state that they had a few episodes of severe ulceration to nail bed. we haven't heard what happened regarding the radiolase equipment but if I do hear anything I will be sure to post.

 

Many thanks both... After trawling the literature, I am beginning to think that any research into radiolase may be a waste of time.... I mean it seems it is a case of 'why fix what ain't broke' ... Phenol certainly seems to be the best approach, is of course widely used, and safe... Despite this, although the literature surrounding radiolase as an alternative seems lacking, many are clearly using it - including NHS Pods - however, procedure apparently varies... Do you think a study for its use as a viable alternative is worth doing... Or should I shelve and think of something else?!

Many thanks for your help.

Kindest regards,

Koota