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

BACKGROUND:

The objective of this study was to assess the safety and efficacy of a 0.5% ferric hyaluronate gel, in reducing adhesions in patients undergoing peritoneal cavity surgery by laparotomy, with a planned 'second-look' laparoscopy.

METHODS:

The study was a randomized (by computer-generated schedule), third party blinded, placebo-controlled, parallel-group design conducted 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 intraperitoneal instillate at the completion of surgery. At second-look 6-12 weeks later, the presence of adhesions was evaluated at 24 abdominal sites.

RESULTS:

Patients treated with ferric hyaluronate had significantly fewer adhesions compared with controls. When adhesions formed, they were significantly less extensive and less severe in the treated group. The American Fertility Society score for adnexal adhesions was reduced by 69% in the treatment group compared with controls. The safety profile of ferric hyaluronate-treated patients was comparable with those treated with lactated Ringer's solution.

CONCLUSIONS:

In conclusion, ferric hyaluronate was safe and highly efficacious in reducing the number, severity and extent of adhesions throughout the abdomen following peritoneal cavity surgery.