Efficacy and Dose Ranging Study of Seroguard
Condition: Adhesion
MeSH terms: Tissue Adhesions
Intervention: Seroguard; Placebo
Intervention description: Seroguard 0.41 g/L solution; Saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The present study was conducted as a double blind trial. Neither a medical investigator, nor patients had access to the treatment assignment code in order to ensure the maximum objective evaluation of the primary endpoint.
Blinding was performed in such a way that disclosing a randomization code of a certain subject excluded a disclosure of the code in general (i.e. the randomization code had no indication to the treatment group). However, there were no cases of the randomization code disclosure in the study
Enrollment: 114.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Adhesion; Efficacy

Summary:

      This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled,
      phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic
      adhesive disease in Study centres in Russia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female patients aged from 18 to 45 years with the confirmed diagnosis of pelvic
             adhesions having indications for surgery (laparoscopic adhesiolysis).

          2. Voluntarily and personally signed and dated Form of Informed Consent.

          3. Female patients with pelvic adhesions confirmed by gynecological and ultrasound
             examination.

        Exclusion Criteria:

          1. Female patients having contraindications to surgical treatment (including acute or
             exacerbated chronical adnexal inflammation);

          2. Body mass index of 30.0 kg/m2 and more;

          3. Known hypersensitivity to the test drug components (Seroguard);

          4. Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;

          5. Refusal to use effective contraception methods throughout the study;

          6. Positive HIV, RW, HBV or HCV test result;

          7. Alcohol abuse, drug addiction, and toxicomania (except smoking);

          8. American Society of Anesthesiologists physical status category III and more (ASA);

          9. Purulent process in the abdominal cavity;

         10. Disseminated endometriosis;

         11. WBC count more than 10*109/L at the complete blood count;

         12. Need of using any drugs during the surgery other than 0.02% chlorhexidine aqueous
             solution throughout the surgery, as well as the test drug or the placebo (0.9% sodium
             chloride) administered intraperitoneally in the end of surgery.

         13. Concomitant diseases that may require conversion of the surgical intervention by other
             indications;

         14. Type I or II diabetes mellitus;

         15. Deep vein thrombosis and/or PATE at the screening or in the medical history;

         16. Renal impairment (glomerular filtration rate less than 60 mL/min/1.73 m2 assessed by
             the CKD-EPI equation);

         17. Liver disorders defined as more than 2-fold rise of the upper limit of normal of one
             of the following enzymes: ALT, AST, GGTP, AP, or more than 2-fold total bilirubin
             increase;

         18. Myocardial infarction within 6 months before screening;

         19. Any concomitant diseases accompanied by heart failure;

         20. Clinically significant ECG changes (as to the investigator's opinion);

         21. Any concomitant diseases accompanied by respiratory failure;

         22. Any oncological disease within 3 years before enrollment into the study;

         23. Systemic inflammatory diseases;

         24. Diseases associated with chronic hemorrhages;

         25. Blood diseases (anemias of any origin, hemoglobinopathies, inherited and acquired
             coagulopathies, hemostasis disorders, thrombocytopenias, and thrombocytopathias, any
             hemoblastoses);

         26. Any other disease that, in the investigator's opinion, may affect study results or
             present an additional threat to well-being of a patient after administration of the
             study drug;

         27. Use of anticoagulants, antiaggregants (except for acetylsalicylic acid at the dose of
             less than 325 mg/day) at the moment of inclusion into the study or planning to do so
             during the study;

         28. Use of drugs with pronounced hemato-, hepato-, or nephrotoxic action, drugs of
             biological origin;

         29. Need to administer cytostatics, systemic glucocorticosteroids, and other
             immunosuppressive agents during the patient's participation in the study.

         30. Participation in any other clinical trial within 30 days before screening;

         31. Contraindications to MRI (presence of implants or implanted electronic devices);

         32. Impossibility or inability to comply with the requirements of the protocol, including
             for physical, psychic or social reasons, in the investigator's opinion.