Human Reproduction, Vol 13, 1480-1485, Copyright © 1998 by Oxford University Press
MH Thornton, DB Johns, JD Campeau, F Hoehler and GS DiZerega
The objective of this study was to assess the safety and to make a
preliminary assessment of the efficacy of 0.5% ferric hyaluronate adhesion
prevention gel in reducing adhesions in patients undergoing peritoneal
cavity surgery by laparotomy, with a planned 'second-look' laparoscopy. The
study was a randomized, open-label, placebo- controlled, parallel-group
design in patients desirous of fertility at the Women's and Children's
Hospital, Department of Obstetrics and Gynecology, University of Southern
California School of Medicine, Los Angeles, California. Female patients
aged 24 to 41 years received 300 ml 0.5% ferric hyaluronate adhesion
prevention gel or lactated Ringer's solution as an intraperitoneal
instillate at the completion of the laparotomy procedure. At second-look
laparoscopy 4-12 weeks after the laparotomy, the presence of adhesions was
evaluated. Haematology and serum chemistry were determined throughout the
study interval. All patients tolerated the procedures well and did not
manifest any serious adverse events. At second-look laparoscopy, patients
treated with 0.5% ferric hyaluronate adhesion prevention gel had
significantly fewer adhesions than control patients. When adhesions did
form, they were significantly less extensive and less severe in patients
who received 0.5% ferric hyaluronate adhesion prevention gel. In
conclusion, 0.5% ferric hyaluronate adhesion prevention gel was safe and
highly efficacious in the reduction of the number, severity and extent of
adhesions throughout the entire abdomen following peritoneal cavity
surgery.
ARTICLES
Clinical evaluation of 0.5% ferric hyaluronate adhesion prevention gel for the reduction of adhesions following peritoneal cavity surgery: open-label pilot study
Livingston Reproductive Biology Laboratory, University of Southern California School of Medicine, Santa Ana, USA.
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