We will of course bring you more updates as soon as we are able.
We have seen examples of some confusion between SPRAYGEL and INTERGEL. The two products and their associated issues are COMPLETELY SEPARATE and UNRELATED. If you think you have had a reaction to INTERGEL – please see the announcement kindly provided to us by Johnson & Johnson at http://www.adhesions.org/whatsnew.htm#intergel
The US clinical trial of SprayGel (Confluent Surgical) has been terminated recently due to some quirks peculiar to the clinical trial design. Setbacks like this are part of the normal process of scientific discovery. It is our understanding that the company and FDA are enthusiastic about re-starting the study with a modified protocol.
The study design required surgeons to irrigate each of the multiple organs to which SprayGel was being applied extensively with saline solution before and after application of SprayGel. Additionally, application was done to all adnexal pelvic organs, whether or not they were injured. This process significantly increased procedure time and resulted in increased manipulation of organs in treated patients, while this was not done in the controls. We know from other studies that more tissue manipulation and longer procedure times themselves may cause tissue damage.
We also know that longer exposure to laparoscopy gases may damage peritoneum. Hence, SprayGel had to work harder than it would otherwise have needed to and thus any potential difference between the treatment and control groups was masked. This would have made it impossible to show enough difference between control (untreated) and treated patients in the size of study being performed. Thus, in order to improve the study design and remove these shortcomings, Confluent elected to stop the current study. One should understand that these studies are expensive undertakings for companies that are often small and with limited budgets. This should not, however, lead one to conclude that the product is or is not working.
Further, the application method used was not representative of what surgeons in Europe and Australia, who are routinely using SprayGel, are doing. They complete their application in usually less than 5 minutes, while in the US trial the application was taking much longer. Confluent is electing to design a new study that more accurately reflects how surgeons outside of the US are using the product.
There have been suggestions that in laparoscopy, the carbon dioxide gas causes a slight degree of acidity which prevents the SprayGel from setting properly. The company has assured us that while in the first minute of application, the setting of SprayGel is slow, after about 1 minute with some replacement of carbon dioxide with air the set up proceeds as expected. If SprayGel is used in gasless laparoscopy or open surgery, this is not an issue at all. Many doctors in Europe and Australia are using SprayGel with results that are satisfactory to them.
This leads me to a related comment about the many posts that appear on this message board regarding patients wanting to go to Germany to have SprayGel used in them.
I am going to repost some comments I made a few months ago. In many other parts of the world, a product can be approved for sale on the strength of animal experiments alone. In the USA however, the FDA usually requires that scientifically conducted clinical trials are performed in humans. There is good reason for this since the FDA has a duty to protect the public health, and until a scientific clinical study demonstrates that a product is safe and also works, the product cannot be sold. Even then, problems may arise once it is used in thousands of patients, as opposed to just the few hundred that participate in the clinical trial. FDA aside, the GOLD standard by which we judge a product is the "double blind, randomized, controlled clinical study".
Until we have such data, it is difficult to make any real conclusions about the product. Very often we receive reports of clinical studies in their early stages, say with 20-30 patients or so. These may certainly provide encouragement, (as is the case for example with Spraygel) but it would be premature to conclude definitively that a product works or does not work until the study is complete. These reports may provide enough encouragement for some people to try that product, if their condition is bad enough that it is worth the risk. For example we have had a number of patients visit doctors in Europe in order to have INTERGEL, or SprayGel, products that are, or were not approved in the USA, at the time. AS MUCH AS WE MAY BE ENCOURAGED BY INDIVIDUAL STORIES ABOUT PRODUCT SUCCESS, WE CANNOT SAY THAT THE ONLY TREATMENT IS BY DR. X USING PRODUCT Y.
For patients suffering with severe ARD (Adhesion Related Disease) there is an understandable desire to try the latest product under investigation. Many people have volunteered for clincial trials. It is your right to do so. But PLEASE remember that until we have had the results of properly conducted clinical studies, we cannot draw any conclusion about the product. INTERGEL, INTERCEED and Seprafilm all have good points, but none of them is perfect. SprayGel and ADEPT show good promise but we do not have large enough clinical studies to make good judgments yet. Furthermore, many of these products are tested in patients that do not have the severe form of ARD, but we hope that sooner or later such tests will be performed. NO MATTER HOW PROMISING A NEW PRODUCT SOUNDS, NO MATTER WHAT YOU HEAR ABOUT IT FROM OTHER PATIENTS, PLEASE REMEMBER THAT NOTHING IS FOOLPROOF. THE PRODUCT MAY NOT WORK IN EVERYONE, INCLUDING YOU. At the same time we must encourage and applaud all the companies (eg J&J, Genzyme, Confluent, ML etc.) who do this type of difficult and expensive work, because it adds to the body of knowledge about adhesions and it increases awareness. The same should be said about doctors. Even the best doctor, with the best techniques will produce adhesions. They do not have magic wands, and the most we can hope for is a doctor who will take the time to learn as much about the problem as possible and to apply that knowledge help his patients. Please let's encourage the medical community to ask these questions and let's try to educate them. I thank all of you for your efforts in this regard.
Sincerely David Wiseman Founder, International Adhesions Society (IAS) http://www.adhesions.org david.wiseman@adhesions.org