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 the incidence, severity, and extent of adhesion
formation at sites without direct surgical trauma or adhesiolysis at
the time of surgical laparotomy. A second look laparoscopy was performed
to assess the adhesions. Twenty seven patients aged 24-41 years
received 300 ml 0.5 % ferric hyaluronate adhesion prevention gel or lactated
Ringer's solution as an intraperitoneat ins tillate at the completion of
the laparotomy procedure. A planned second- look laparoscopy, 8-12
weeks after the laparotomy was performed to evaluate the presence of
adhesions. All patients tolerated the procedure and did not manyeest any
serious adverse events. There was one patient developed minor intestinal
leak that cldsed spontaneously after 3 weeks. 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 signtficantly less extensive and less severe in patients
who received 0.5 96 ferric hyaluronate adhesion prevention gel. In
conclusion 0.5 % ferric hyaluronate adhesion prevention solution was
safe and highly efficacious in reduction of the number, severity, and ex-tent of adhesions throughout the entire abdomen following surgical laparotomy. |