My appologies for reading the clinical trials incorrectly :o)
I think I've gleaned what may be the reason for your interest in this forum.
Ironically, you have entered into a discussion with an adhesion sufferer who has no intention to undergo another surgery (unless fully obstructed, which I doubt will happen), and who takes no pain meds. I too believe that narcotics are not the answer for me, but I also understand that too many patients suffer needlessly because of Drs who believe what you do. So your remarks in a following post concerning pain meds does not personally concern me. I do, however, find it insulting that you refer in that post to prescribing narcotics for "real pain", inferring that adhesion pain is not real. Forgive my being so forward as to say, but I believe that the adhesion pain that I have experienced has been somewhat akin to a man having his privates grabbed, twisted, and then pulled down real hard. Please feel free to condescend to me that this experience for a male does not cause "real pain".
Below you will find two articles that I found in regards to clinical trials on SprayGel.
Whatever your underlying intent is, please know that your posts appear provocative and high-handed. If you continue to feel the need to distract the forum, have at it. If, however, you want to help those who deal with the daily struggles that accompany problematic adhesions, I respectfully suggest that you approach the forum in a positive manner, rather than telling us this is all we have and deal with it. Without hope, some of these people may not be able to carry on with as few meds as they do. Some of these people deal with bowel resections resulting from adhesions. Some have little or no urinary function. Some are in serious health crisis. Do you really wish to take the hope away from these patients?
If so, and you are truly who you say you are, then shame...
Best wishes, Clare
"September 6,2000
Confluent Surgical, Inc. Begins SprayGel™ Adhesion Barrier System Clinical Trial
BOSTON, Nov. 30 /PRNewswire/ - -Confluent Surgical Inc. announced today that the Company has begun a clinical trial for the SprayGel™ Adhesion Barrier System.
SprayGel is designed to reduce or eliminate adhesions after gynecological surgery. Adhesions are a leading cause of pain, infertility, and other complications following such surgery. The study is being conducted at two clinical sites in Europe, and will include up to 50 patients undergoing surgery for removal of uterine fibroid tumors (myomectomy). The clinical endpoint of the clinical trial will be the reduction or elimination of adhesions to the uterus.
"We are pleased to have attained this important milestone in the development of what promises to be first truly effective therapeutic approach for the prevention of post-surgical adhesions" said Amar Sawhney, Ph.D., Founder, President, and CEO of Confluent.
Based on proprietary hydrogel technology, SprayGel consists of two synthetic liquids that when mixed together rapidly cross-link to form an absorbable biocompatible hydrogel in situ, at the application. The polymerization occurs very rapidly (within seconds) with no heat evolved and no external energy source required (e.g., light or heat source). SprayGel is sprayed onto tissues using an air-assisted sprayer that can be used in either laparoscopic or open procedures. The hydrogel forms a flexible adhesion barrier that is tightly adherent to tissue, remains intact for about a week, and is then absorbed. This allows surgically injured tissues to heal without forming a scar or adhesion with surrounding organs.
"SprayGel is a breakthrough in adhesion barriers because it can be easily applied laparoscopically and remains on the tissues where it is applied during the critical wound healing period." Said Dr. Alain J.M. Audebert, Gynecologic Surgeon, Institut Robert B. Greenblatt, Bordeaux, France
Confluent Surgical, Inc. is a privately held medical device company formed in 1998, that is focused on developing in-situ polymerized biomaterials to address unmet or under served clinical needs associated primarily with the prevention of Post Surgical Adhesions."
"Product Offers Promise of Improved Postoperative Outcomes and Quality of Life for Millions of Women
Waltham, MA – June 17, 2002 – Confluent Surgical, Inc., today announced the commencement of its pivotal U.S. trial for the SprayGel Adhesion Barrier in Prevention of Pelvic Adhesions In Laparoscopic Surgery, the PREVAIL Study. Confluent Surgical believes that the SprayGel Adhesion Barrier will prevent and reduce adhesions that are associated with severe postoperative pain and other side effects, which affect millions of women annually.
The first procedure in the PREVAIL Study was performed last Friday by Michael L. Twede, MD, FACOG, and Dale A. Sundwall, MD, FACOG, Medical Directors at the Salt Lake City Women’s Center. Drs. Twede and Sundwall are considered experts in the treatment of endometriosis and adhesions and are respected as highly skilled surgeons. Dr. Twede states, "Based on the early published results, SprayGel appears to represent a breakthrough in adhesion prevention. It is unique in its ability to be applied laparascopically and remain in place as a barrier for five to seven days, the period when adhesions normally form. If the results from the initial pilot study are replicated in this pivotal study, this product would prevent or significantly reduce patient trauma and costs associated with additional surgery for adhesions."
Adhesions are fibrous bands of tissue between adjacent organs of the body. They typically occur as a result of inflammation incident to surgery and can cause severe pelvic pain and infertility. Adhesions start to form within three hours of surgery and will cease forming when the surgical sites heal, usually within seven days following surgery. The SprayGel Adhesion Barrier is designed to protect the tissues during this critical healing period. It is estimated that adhesions affect over two million women and men in the U.S. and that the potential U.S. market for abdominopelvic adhesion management is $400-$500 million.
"Based on its early performance in prior pilot trials as well as our early commercial success in Europe, we believe that SprayGel will become the product of choice for gynecologic surgeons to prevent postoperative adhesions," stated Amar S. Sawhney, President and CEO of Confluent Surgical, Inc. " This uniquely adherent, blue polymer gel offers surgeons what they have been lacking in previous products; the ability to see it easily, apply it easily and maintain tissue coverage during the critical days following surgery. We are excited to begin this multicenter pivotal trial as a step towards bringing SprayGel to market in the United States."
About Confluent Surgical, Inc.
Confluent Surgical, Inc., is a privately held company developing products based on its platform technologies of in-situ polymerized biomaterials and associated delivery systems. The company believes that its technologies will have applications in major medical markets.
The SprayGel Adhesion Barrier System received CE mark in November 2001, and has been introduced in major European markets and Australia. Based on European and US clinical pilot studies, the patented and proprietary synthetic material has been shown to significantly reduce adhesion formation following abdominopelvic surgery. The SprayGel Adhesion Barrier is not commercially available in the United States.
For additional information please contact Roberta Sawyer at rsawyer@confluentsurgical.com or visit the Confluent's website at http://www.confluentsurgical.com."
At Thu, 9 Jan 2003, Dr.Moore wrote:
>
>At Thu, 9 Jan 2003, clareS wrote:
>
>My credentials are simple- I'm a board certified ob/gyn, finished
>residency in 1999. I actually trained with "R Dunn" (Randy Dunn who
>many people say looks like me) who wrote the 2nd article you quoted. He
>is an infertility specialist in Houston, Texas.
>
>As for the articles you pasted in your response, let me first apologize.
>Reading medical journals is tough and there are whole classes on how to
>do so.
>
>The articles are junk- the first one was tested on 8 pigs (porcine is a
>fancy way of saying pig (not human)), the key phrase is "CONCLUSIONS:
>Polyethylene glycol (SprayGel) merits further investigation as an
>effective barrier to the formation of post-operative adhesions in this
>porcine model." Translation- we need more studies to see if this works
>in pigs.
>
>The second one was on rats and bunnies- Dr. Dunn should be ashamed to
>harm those furry little creatures. The studies had small numbers (16
>rats and 20 bunnies) and concluded that larger animal studies were
>needed.
>
>If this is "proof" then I am wrong. However, adhesion formation in
>rats,pigs, and rabbits may be different than in humans. This is a step
>in the right direction, although the pig study showed no statistical
>difference in adhesion formation with or without Spray gel. But as a
>physician, before I go spraying some goo in my patients, I want PROOF
>that it works. Not a bunch of testimonials on a message board or a
>study on 20 bunnies.
>
>I have great compassion for my patients. I give them the best possible
>care in one of the biggest, most advanced hospitals in the US. And
>above all, I gaurd them from doing harm to themselves (and make no
>mistake, I think doing unneccessary surgery and/or using unproven
>medicines is harmful). Because the first thing we learned as medical
>students was "Primum non nocere," Do no harm.
>
>In closing someone made a poke at my responding to this message board-
>something along the lines that if I was so good why did I have time to
>respond to this board. Well, I wonder why there aren't more physicians
>on this board- do any of you wonder why also? And the reason I have so
>much free time is simple- I'm single (soon to be married) and just
>joined a new practice. I have buku free time and surf the net quite
>often trying to learn what my patients are reading. By the way,
>Obgyn.net is a great site for patient info.
>
>>Dear Dr. Moore:
>>
>>Okay, okay, I wasn't going to jump into this as I'm busy enough as it
>>is, but hey, there's some things I really gotta say here :o)
>>
>>Perhaps I might suggest that you put your credentials on the figurative
>>table here, and no, I'm sorry but a bit more than "OB/GYN" and "all lot
>>of experience" would be appreciated.
>>
>>You stated that "A real scientific experiment involves a placebo arm,
>>where patients are given similar treatment but without the "magical"
>>cure or medicine. Because as all of you know some people don't form
>>adhesions- this means that sometimes "nothing" works to prevent
>>adhesions. And that's where barriers like Intercede (and probably this
>>Spraygel) failed."
>>
>>Perhaps you are not aware that trials for SprayGel have been quite
>>successful overseas, and that there are ongoing clinical trials (yes,
>>with a placebo arm) currently underway in the USA as I type. I went to
>>the PUBMED site that you laud, and I simply typed in SprayGel, and lo
>>and behold this is what I found!!
>>
>>"1: Hum Reprod 2001 Dec;16(12):2718-23 Related Articles, Links
>>
>>Evaluation of a sprayable polyethylene glycol adhesion barrier in a
>>porcine efficacy model.
>>
>>Ferland R, Mulani D, Campbell PK.
>>
>>Women and Infants Hospital, Providence, RI 02905, USA.
>>roger_ferland@brown.edu
>>
>>BACKGROUND: The formation of adhesions following pelvic surgery remains
>>one of the leading causes of infertility, small bowel obstruction and
>>re-operation for pelvic pain. A novel hydrophilic polyethylene glycol
>>based adhesion barrier (SprayGel) is formed by simultaneously spraying
>>two liquid precursors onto surgical sites. The liquids polymerize to
>>form a gel that effectively coats and adheres to tissue. After about 5
>>days, the hydrogel layer is absorbed and subsequently undergoes renal
>>clearance. It is believed that the presence of such a barrier would
>>inhibit the formation of adhesions following surgical insult. METHODS:
>>A porcine adhesion model was developed wherein bilateral uterine horn
>>transection and re-anastomosis, along with peritoneal side wall excision
>>was performed via laparotomy. In each animal (n = 10, including the
>>pilot study) one pelvic side wall was treated with adhesion barrier,
>>while the contralateral side remained untreated. RESULTS: At second
>>look laparoscopy, 90% of the untreated sites had adhesions, compared
>>with 30% of the treated sites (P = 0.006). Also observed were
>>statistically significant reductions in the adhesion extent (P = 0.029)
>>and adhesion severity scores (P = 0.023) at the treated sites. However,
>>if the pilot study was excluded (n = 8) the differences obtained were no
>>longer significant. CONCLUSIONS: Polyethylene glycol (SprayGel) merits
>>further investigation as an effective barrier to the formation of
>>post-operative adhesions in this porcine model.
>>
>>PMID: 11726601 [PubMed - indexed for MEDLINE"
>>
>>~And~
>>"1: Fertil Steril 2001 Feb;75(2):411-6 Related Articles, Links
>>
>>Evaluation of the SprayGel adhesion barrier in the rat cecum abrasion
>>and rabbit uterine horn adhesion models.
>>
>>Dunn R, Lyman MD, Edelman PG, Campbell PK.
>>
>>OB/GYN Associates, PA, 7550 Fannin, Houston, Texas 77054, USA.
>>obgynassociates.com
>>
>>OBJECTIVE: To evaluate the efficacy of a new adhesion barrier in the
>>prevention of postoperative adhesion formation. DESIGN: A double-blind
>>controlled study of the efficacy of SprayGel in reducing postoperative
>>adhesion formation in two animal models. SETTING: Animal care facility
>>of a contract testing laboratory. ANIMAL(S): Sixteen Sprague-Dawley
>>male rats were randomly allocated into two groups in the cecum abrasion
>>model. Twenty New Zealand white female rabbits were randomly allocated
>>into two groups in the uterine horn abrasion model. INTERVENTION(S): In
>>the rat model, the cecum was abraded with gauze and the abdominal wall
>>was abraded with a scalpel. Treated animals received SprayGel coating
>>on injured surfaces; control animals received no treatment. In the
>>rabbit model, uterine horns were abraded with a scalpel. Treated
>>animals received SprayGel coating on injured surfaces; control animals
>>received no treatment. MAIN OUTCOME MEASURE(S): Postoperative adhesion
>>formation. RESULT(S): In the rat model, SprayGel was found to
>>significantly reduce the incidence of adhesions, which formed in 7 of 8
>>control rats compared with 1 of 8 treated rats. In the rabbit model,
>>SprayGel was found to significantly reduce both the extent and severity
>>of adhesions. CONCLUSION(S): Application of SprayGel in two animal
>>models reduced formation of postoperative adhesions. Further
>>investigation in large animal and clinical settings is warranted.
>>
>>PMID: 11172849 [PubMed - indexed for MEDLINE]"
>>
>>There you have 2 studies, one on humans sitting right there in front of
>>you! With all due respect, I suggest that you, Dr. Moore could have
>>done the same, and got the identical results. The clinical trials on
>>Spraygel are not anecdotal, and the results are not "magical" - the
>>results are a significant reduction of adhesions at second look
>>laparoscopy which merits more studies (currently underway).
>>
>>I find your suggestion that we do our own research high-handed, and
>>insulting. Obviously, you have very little idea whom you are addressing
>>with such a sweeping assumption. I find your comments regarding Dr.
>>Krschinski in Germany ("Dr. K should remember the first rule of
>>medicine, Primum non nocere- first do no
>>harm. And if his treatment works, then prove it. It's quite simple to
>>prove medical therapies work, I would love to start using his techniques
>>tomorrow if they worked.")
>>simply deplorable, as well as unprofessional. That is why I ask you to
>>put your credentials on the table - I have a difficult time believing
>>that you are who you say you are, and not some bored troll. These Drs
>>in Germany have proven that their medical treatment works (at least as
>>far as significant reduction of adhesions is concerned) so you'd best do
>>your research and get busy!
>>
>>On a more basic note, Dr. Moore, people with problematic adhesions deal
>>with very real issues, and it is Drs who believe only what they have
>>been taught who do us (and all of their patients) a disservice.
>>
>>Best wishes.
>>Clare
>>
>>At Thu, 9 Jan 2003, Dr.Moore wrote:
>>>
>>>Some pretty harsh responses from this board. I suspected that would be
>>>a likely response. I have had a lot of experience with adhesions and it
>>>is a very frustrating problem. And I have done a lot of surgery to
>>>remove adhesions (in fact I did a laparoscopic lysis of adhesions
>>>today), with mixed results.
>>>
>>>To dispel a few incorrect statements-
>>>1) I am only 33, so my knowledge is not outdated. I finished residency
>>>in 1999.
>>>
>>>2) Never did I say "Go home and deal with it" although this may be
>>>better advice than that given by some of the people on this website. You
>>>see the problem with "I did this and now I'm better" advice (called
>>>anecdotal evidence in medical terms) is that it just isn't valid.
>>>
>>>A real scientific experiment involves a placebo arm, where patients are
>>>given similar treatment but without the "magical" cure or medicine.
>>>Because as all of you know some people don't form adhesions- this means
>>>that sometimes "nothing" works to prevent adhesions. And that's where
>>>barriers like Intercede (and probably this Spraygel) failed.
>>>
>>>I always tell my patients that if a treatment is not proven to work, but
>>>works for them (eg herbal supplements) they should do it. As long as it
>>>is not super expensive (eg flying to Germany and paying out of pocket
>>>for surgery) and isn't harmful (like surgery can be). Dr. K should
>>>remember the first rule of medicine, Primum non nocere- first do no
>>>harm. And if his treatment works, then prove it. It's quite simple to
>>>prove medical therapies work, I would love to start using his techniques
>>>tomorrow if they worked.
>>>
>>>Finally, do your own research. THE PLACE for researching medical
>>>literature is PUBMED. Here is the website, search for your self- the
>>>website gives you abstracts (short summaries of the experiments/clinical
>>>trials) and the original source so you can go to the library and look at
>>>the original articles. Here is the website:
>>>
>>>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi
>>>
>>>Oh, one last point- The "you don't know what we're going through"
>>>argument also doesn't work in medicine. I don't know Dr. K's story,
>>>but I doubt he has pelvic adhesive disease. And I assure you that to be
>>>a good cardiologist you don't have to have a heart attack and to be a
>>>good neurosurgeon you don't have to have a brain tumor.
>>>
>>>At Wed, 8 Jan 2003, Koolinsask@aol.com wrote:
>>>>
>>>>Dear Dr.Moore, yes, I would have to agree with Sally, the sad part is, you
>>>>nor any doctor out there, can relate to what pain we go through, the daily
>>>>struggles, the depression, some of us are unable to work any longer, many of
>>>>us are very young, with very young children, just beginning our lives!!!!!
>>>>Only to be stripped of a "normal life". Too many doctor's tell us to go home,
>>>>suffer, sorry there is nothing we can do! This attitude has got to stop, we
>>>>need help, and we for so long have relied on our caregiver's to educate
>>>>themselves, to help us......well, it hasn't happened, we have come together
>>>>here on this forum, to help one another, to give support, to FIND help...if
>>>>that means spending money, money in which, is nothing when it comes to one's
>>>>health, then so be it!!!!!! I would also advise yourself, and hundreds of
>>>>other's out there, to please consider, researching, and try to understand
>>>>what it is that each and everyone of us is going through, it's an utter
>>>>nitemare!!!!! Please, i am not trying in anyway shape or form, to discredit
>>>>anyone doctor out there, but rather, pleading with you , to learn more, and
>>>>instead of telling us to go home, tell us, you are trying, you are
>>>>researching, and that you CARE, AND UNDERSTAND!!!!! We are all human, just
>>>>like your' wife, your' daughter, son , husband, mother , father etc......we
>>>>want to live, we want to see our children grow up, we want to take care of
>>>>our children, and get through our day's , just like you do!!!!!!!!!!! Thank
>>>>you for at least dropping in, and maybe reading through some of our stories,
>>>>that is a very nice first step....please, come back, and inform us, of any
>>>>new happenings that you may find out there!!!!!!
>>>>
>>>>Cherryl