Clinical evaluation of 0.5% 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 apreliminary assessment of the efficacy of 0.5% ferric hyaluronate adhesionprevention gel in reducing adhesions in patients undergoing peritonealcavity surgery by laparotomy, with a planned 'second-look' laparoscopy. Thestudy was a randomized, open-label, placebo- controlled, parallel-groupdesign in patients desirous of fertility at the Women's and Children'sHospital, Department of Obstetrics and Gynecology, University of SouthernCalifornia School of Medicine, Los Angeles, California. Female patientsaged 24 to 41 years received 300 ml 0.5% ferric hyaluronate adhesionprevention gel or lactated Ringer's solution as an intraperitonealinstillate at the completion of the laparotomy procedure. At second-looklaparoscopy 4-12 weeks after the laparotomy, the presence of adhesions wasevaluated. Haematology and serum chemistry were determined throughout thestudy interval. All patients tolerated the procedures well and did notmanifest any serious adverse events. At second-look laparoscopy, patientstreated with 0.5% ferric hyaluronate adhesion prevention gel hadsignificantly fewer adhesions than control patients. When adhesions didform, they were significantly less extensive and less severe in patientswho received 0.5% ferric hyaluronate adhesion prevention gel. Inconclusion, 0.5% ferric hyaluronate adhesion prevention gel was safe andhighly efficacious in the reduction of the number, severity and extent ofadhesions throughout the entire abdomen following peritoneal cavitysurgery.