I am frequently asked to comment on Cryoshape Procedure. This is a summary of my opinions and findings concerning this procedure. I have personally observed the procedure and do not endorse it. Below, I outline the reasons for my objections.
CryoShape is an invasive method of freezing keloid tissue, using a long, thick needle, much like a metallic knitting needle. This needle must be inserted into and pass through the keloid and pushed forward to exit from the opposite side of the keloid. The needle is then connected to a source of liquid nitrogen, allowing free flow of liquid nitrogen through the needle. This cools the needle, resulting in the freezing of the keloid tissue. There are, however, several serious issues with this method of freezing keloids.
1- Lack of Scientific Evidence: There is absolutely no evidence that freezing a keloid by CryoShape is any better than standard non-invasive Cryotherapy. The makers of this device have never performed any studies to compare the two techniques.
2- Highly Invasive Method: Puncturing keloids with a thick needle result in creating a deep injury, a longitudinal and wide tunnel inside the keloid tissue with two open holes, the entry point, and the exit site. Additional punctures and injections are also required to numb the tissue to allow for insertion of the CryoShape needle. There is no need for such an invasive method when keloids can be frozen with simple cotton swabs.
3- Risk of Infection: Cryotherapy obviously results in tissue damage, blister formation, oozing, leaking etc. The damage to the keloid from multiple puncture wounds puts the keloid at a greater risk of developing an infection.
4- Lack of Control over the Depth of the Freeze: With rare exceptions, keloids are never symmetrical. Each keloid has its own unique three-dimensional shape. With the CryoShape needle in place, especially for long and wide keloids, a round and symmetrical ice ball forms around the needle, over which the operator has absolutely no control. He cannot force the shape of the ice ball to match the contour of the keloid. The operator of the device has absolutely no control over the depth of the freeze. The best he can do is to insert the CryoShape Needle somehow through the central axis of the keloid. The procedure is continued until the operator can visually see superficial freezing of the keloid; however, he cannot see how much of the normal tissue located under or around the keloid will become damaged by his freezing.
5- Injury from CryoShape needle can Trigger Keloid Formation: Keloid is a hereditary disorder. The formation of keloid is triggered by injury to the skin. In patients who are prone to forming keloids even slightest injury to their skin, such as piercing their earlobes can trigger keloid formation. The CryoShape needle is at least 20 times thicker than the needles used to puncture earlobes. The damage caused by the CryoShape procedure is severe enough to trigger keloid formation.
6- Cost: Obviously, a plastic surgeon who spends an hour performing this procedure in an operating room setting will charge the patient accordingly. This cost, coupled with that of the needle itself, which is several hundred dollars, must be taken into consideration.
7- Lack of Proper Research: CryoShape has never been studied properly to compare its efficacy to standard methods of Cryotherapy. Indeed, there is hardly any literature that discusses the effectiveness and safety of this extremely invasive method. The device has been in use for over a decade now, and there is hardly any peer-reviewed medical literature about it. The Cryoshape.com website points to one study that was published in 2003, reporting on only ten patients with 12 scars or keloids. This study reports an average of 51.4 percent of scar volume reduction was achieved after one session of intralesional cryosurgery treatment.
In my opinion, the cost, along with the tissue injury and risk of infection is not worth a 51.4 percent scar volume reduction. A more recent publication in 2008 that reported on 11 scars, concluding that there was a significant reduction in concern and deformity scores compared with those before the cryo treatment. The article is not at all clear about what a reduction in concern and deformity scores means and why did the investigator not use Reduction in Keloid Volume as an indicator of efficacy and instead they came up with a convoluted endpoint for their very small study. The report does not mention the response rate, or what percentage of patients had the total disappearance of their scars. The company marketing the device, before advocating this method of treatment and this procedure, has the duty of conducting proper randomized clinical trials to compare the efficacy and safety of the CryoShape treatment to standard Cryotherapy. I have personally alerted the company about the need for such studies. The Cryoshape.com website, in its FAQ page, indicates that in over 97% of the cases performed to date, no scar recurrence was observed. Most patients require only a single procedure to significantly reduce the size and shape of keloid or hypertrophic scars. This claim is only made on the website and not published or even referenced in any peer-reviewed medical literature. This claim contradicts the other reports that are cited on their website.
8- No Cure for Keloids: Keloids come in all forms, shapes, and sizes. Many keloids are extremely thin, even thinner than the CryoShape needle itself. To date, there is very little known about Keloid Disorder. Its biology, genetics, epidemiology, and pathophysiology, all remain obscure. Much research is needed to make advances in this field. There is almost no evidence to support the claims made on the CryoShape website. There are no reasons to believe that simply inserting a needle inside a keloid and freezing it from inside will cure this condition. Though the website indicates that this is true in 97% of all cases, they have not substantiated their claims with hard facts. These claims, along with other data, should be supported by peer-reviewed medical research, which to this date has never been performed.
9- Lastly, it is CRYOTHERAPY that works not inserting a thick needle inside a keloid. I strongly believe that Cryotherapy is a very effective method of treating keloids. Effective cryotherapy can be safely applied to any keloid using a cotton swab, without the need for injecting or injuring the keloid tissue by CryoShape procedure. For all the reasons stated above, I strongly opine against using this invasive method. The medical and dermatology community has not endorsed this procedure either; hence after many years of marketing this procedure, hardly any physician in this country is using the device. There are only a few places in the United States that advocate or provide this costly procedure.
Michael H. Tirgan, MD