CLINICAL-EVALUATION OF 0.5-PERCENT FERRIC HYALURONATE ADHESION PREVENTION GEL FOR THE REDUCTION OF ADHESIONS FOLLOWING PERITONEAL-CAVITY SURGERY - OPEN-LABEL PILOT-STUDY

The objective of this study was to assess the safety and to make a pre liminary assessment of the efficacy of 0.5% ferric hyaluronate adhesio n prevention gel in reducing adhesions in patients undergoing peritone al cavity surgery by laparotomy, with a planned 'second-look' laparosc opy. The study was a randomized, open-label, placebo-controlled, paral lel-group design in patients desirous of fertility at the Women's and Children's Hospital, Department of Obstetrics and Gynecology, Universi ty of Southern California School of Medicine, Los Angeles, California. Female patients aged 24 to 41 years received 300 ml 0.5% ferric hyalu ronate adhesion prevention gel or lactated Ringer's solution as an int raperitoneal instillate at the completion of the laparotomy procedure. At second-look laparoscopy 4-12 weeks after the laparotomy, the prese nce of adhesions was evaluated, Haematology and serum chemistry were d etermined throughout the study interval. All patients tolerated the pr ocedures web and did not manifest any serious adverse events. At secon d-look laparoscopy: patients treated with 0.5% ferric hyaluronate adhe sion prevention gel had significantly fewer adhesions than control pat ients. When adhesions did form, they were significantly less extensive and less severe in patients who received 0.5% ferric hyaluronate adhe sion prevention gel, In conclusion, 0.5% ferric hyaluronate adhesion p revention 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.