The FDA recently approved Adept from Innovate PLC (formerly ML Labs) as an adhesion prevention agent following gynecologic laparoscopic surgery. I know this product well as I was involved in the original US Pilot study in 2001. There are few products approved for this use at open surgery but none before have been approved for laparoscopic surgery. Many have tried and failed! Adaept is essentially a starch based solution (4% Icodextrin) that is placed in the abdominal and pelvic cavity during surgery. It works via osmotic gradients to pull water into the pelvic cavity. This is the old “hydroflotation” strategy whereby fluid causes cut structures to float away from each other and not adhere during healing. This concept was originally developed with plain ringer’s solution then replaced with Hyskon. Resuts were very minimal when these were fianlly tested (despite years of use).
Adept was originally developed for use in peritoneal dialysis. The US trials for approval for use in surgery demonstrated a reduction in the number of adhesions when it was used versus controls. Adept 45% with a decrease in scar sites versus 35% in the control arm. Interestingly, for the two other main outcomes of efficacy Adept failed to meet significance. The FDA panel voted to approve it nonetheless in view of its excellent safet record and use outside the USA since 1999 with minimal adverse effects. Actual efficacy is however less than I would have liked to see in this study.
Other devices available currently in the market include Interceed from J&J (not approved for laparoscopic use) and Seprafilm (not approved for laparoscopic use– potentially better but a NIGHTMARE to use at laparoscopy since it sticks to everything then disolves.
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Glad you liked the product. However, your statement, “It works via osmotic gradients to pull water into the pelvic cavity,” describes icodexTRAN which is the tradename for Hyskon. This is why there has been multiple complications with the Hyskon product.
IcodexTRIN the Tradename for Adept have a completely different mechanism of action of being a slowly absorbed (by the lymphatics) molecule. Average absorbtion time for 1L was shown to be 4-5 days.
Thanks for your post but you are mistaken and notr correct. Hyskon (Goodness- I haven’t used that crap since 1994) is actually 32 percent dextran-70. THe complications from Hskon are not due to its mechanism of action. The complications were rare and were mainly allergic. Case reports suggested that Dextran 70 may cause a syndrome resembling disseminated intravascular coagulation — very rare. The allergic response to Hyskon consists of both an anaphylactic and an anaphylactoid component. The pulmonary edema and fluid overload was rare as well. The problem with it was it was like glue when it dried and it simply did not work well at all when tested for adhesion prevention and for hysteroscopy was very limited in what could be done with it vs saline glycine etc. in prospective trials.
Yes, I was not 100% clear when I drew the comparison of the two products. The mechanism of hyskon drawing fluid into the peritoneum and Adept staying put without absorption is “technically different” but THEY BOTH PREVENT ADHESIONS VIA THE SAME MECHANISM - namely the “hydroflotation” mechanism. The part that differes is how they get the fluid there but the fluid is the same idea. The idea is that a fluid in the peritoneal cavity will float the structures at risk apart. This is the same. It also explains the very limited efficacy of either product- a main reason why it is not being used widely at all.
I am very familiar with both.
why it is withdrawn from indian market
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