Reduction of post-surgical adhesions with ferric hyaluronate gel: a European study

BACKGROUND: The objective of this study was to assess the safety and effica cy of a 0.5% ferric hyaluronate gel, in reducing adhesions in patients unde rgoing peritoneal cavity surgery by laparotomy, with a planned 'second-look ' laparoscopy. METHODS: The study was a randomized (by computer-generated s chedule), third party blinded, placebo-controlled, parallel-group design co nducted at five centres in Europe. Females aged 18-46 years received 300 ml ferric hyaluronate (n=38) or lactated Ringer's (n=39) as an intraperitonea l instillate at the completion of surgery. At second-look 6-12 weeks later, the presence of adhesions was evaluated at 24 abdominal sites. RESULTS: Pa tients treated with ferric hyaluronate had significantly fewer adhesions co mpared with controls. When adhesions formed, they were significantly less e xtensive and less severe in the treated group. The American Fertility Socie ty score for adnexal adhesions was reduced by 69% in the treatment group co mpared with controls. The safety profile of ferric hyaluronate-treated pati ents was comparable with those treated with lactated Ringer's solution. CON CLUSIONS: In conclusion, ferric hyaluronate was safe and highly efficacious in reducing the number, severity and extent of adhesions throughout the ab domen following peritoneal cavity surgery.