The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA)
kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing
surgery involving the ovaries.
Adhexil™ contains the components that form the anti-adhesive barrier, BAC and Thrombin.
Thrombin is a sterile solution, containing highly purified human thrombin. BAC is a sterile,
solution whose principal component is a concentrate of human fibrinogen. Adhexil™ is
supplied in two vials and an application device.
- Female patients aged 18-45 years at screening
- Patients undergoing elective laparoscopic surgery due to known or suspected bilateral
- Pregnant (including ectopic pregnancy) or breastfeeding patient
- Patients with a documented diagnosis of cancer
- Patients with a lymphatic, hematologic or coagulation disorder
- Patients with a known or suspected hypersensitivity to blood, blood products or any
constituent of Adhexil™
- Patients who are immunocompromised, possess autoimmune disorders, or who are
routinely taking anticoagulants.
- Patients who have participated in another clinical study within 30 days of enrolment.
- Investigator's opinion that the patient is medically unfit or would be at major risk
if enrolled into the study.