Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy

Preoperative Inclusion Criteria:

• Understand and be able to follow the requirements of the protocol including personally signing and dating an IRB approved Informed Consent Form prior to undergoing any protocol related procedures,
• Be a premenopausal female, > 18 and \< 44 years old,
• Be thought to have uterine fibroids requiring laparoscopic abdominopelvic surgery that will require a > 3 cm posterior uterine incision (including repeat myomectomy/previous uterine artery embolization for fibroid), and/or +/- adhesions, and/or +/- endometriosis, and/or +/- adenomyosis and/or ovarian cyst(s),
• Wish to retain her fertility and be considered to clinically benefit from a SLL, in the investigator's opinion,
• Have a willingness to undergo a second look laparoscopy if surgeon considers it clinically beneficial to the subject,
• Have a negative pregnancy test within 5 days of surgery,
• Agree to avoid pregnancy using adequate forms of contraception (oral contraceptive pill, condom, no sexual intercourse), and is aware and agrees to avoid pregnancy for a minimum of 12 weeks or to SLL (whichever is greater) to allow for healing of the uterine scar following myomectomy,
• Is willing, able and likely to fully comply with study procedures and restrictions including follow-up,
• Be in good health including an ASA (American Society of Anesthesiologists) score of 2 or less,
• Have undergone a satisfactory physical and medical assessment with no clinically significant and relevant abnormalities.

Intraoperative Inclusion Criteria:

• The subject underwent a laparoscopic myomectomy with at least (1) posterior uterine serosal incision of > 3 cm in length,
• The subject meets all intraoperative inclusion/exclusion criteria prior to randomization,

And

• At the completion of the procedure, before randomization, the surgeon believes that the subject will clinically benefit from a second look laparoscopy to preserve fertility.

Preoperative Exclusion Criteria:

• Are unable to give their own written informed consent,
• Have completed her family planning with no desire to maintain fertility,
• Are considered to have no potential clinical benefit from a second look laparoscopy,
• Are currently pregnant (including ectopic pregnancy),
• Are breastfeeding,
• Are within 6 weeks post-partum,
• Have received or are expected to receive another anti-adhesive treatment within 30 days prior to enrollment or during enrollment up to adhesion evaluation at second look laparoscopy,
• Are currently or have been enrolled within the last 30 days in another interventional study.
• Have received or are expected to receive any other investigational product or technique within 30 days prior to or during enrollment,
• Have had cancer within 5 years of the initial surgery with the exception of basal cell carcinoma,
• Have known allergy to dextran, PEG, or FD\&C Blue #1,
• Have had bilateral salpingectomy,
• Have had a hysterectomy,
• Are scheduled to undergo concomitant non-gynecologic surgery,
• Have pre-operative imaging results with:
• Largest fibroid diameter \< 2 cm, or
• Largest intramural fibroid diameter >10 cm, or
• More than 5 intramural fibroids with a diameter of > 8 cm, and/or
• Adenomyoma >10 cm.
• Have a history where it is expected that complete adhesiolysis will be impossible,
• Have clinically significant abnormal blood results,
• Have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic, hematological or coagulation disorders,
• Have insulin dependent diabetes mellitus,
• Are receiving concurrent systemic corticosteroids, antineoplastic agents and/or radiation therapy,
• Have had previous abdominal or pelvic radiation therapy,
• Have active pelvic or abdominal infection, or other active infection with fever >100°F/38°C,
• Have a known history of methicillin-resistant Staphylococcus aureus (MRSA), HIV, HBV or HCV.

Intraoperative Exclusion Criteria:

• Have cancer detected at surgery,
• Are pregnant, including ectopic pregnancy,
• Have a non-gynecologic surgical procedure or entry into the bowel, bladder, or ureter,
• Have a hysterectomy or other gynecologic procedure that would render the subject unable to conceive,
• Have incomplete lysis of any pre-existing pathological adhesions,
• Have extensive enterolysis,
• Have incomplete surgical treatment of endometriosis,
• Receive the administration of a product that will interfere with the application of Actamax™ Adhesion Barrier,
• Receive the use of an approved or unapproved product or strategy for the purpose of preventing adhesion development,
• Receive fibrin glue, surgical sealant, or other hemostatic agent,
• Undergo an open procedure (other than mini laparotomy to remove fibroids),
• Undergo a posterior colpotomy,
• Undergo insufflation with a gas other than CO2,
• Undergo Laprolift or similar device for elevation of the abdominal wall, as an alternative to CO2 insufflation,
• Undergo abdominal cavity heating, humidification or oxygenation,
• Receive irrigants containing, glucocorticoids, antihistamines, heparin or antiseptic additives,
• Have any instillates left at the end of surgery,
• Have a postoperative drain,
• Undergo laparoscopic myomectomy without at least one posterior uterine serosal incision of > 3 cm in length,

• Undergo a diagnostic hysteroscopy or polypectomy or therapeutic hysteroscopy which includes any of the following:

  1. Undertaken during or following the laparoscopic myomectomy,
  2. Treatment of fibroids >3 cm,
  3. Solution other than Lactated Ringer's Solution (LRS) used for uterine distention,
  4. Laparoscopic filming commenced after removal of LRS.
• If, in the opinion of the surgeon, subject would have no clinical benefit for a SLL.