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Women undergoing laparoscopic abdominopelvic surgery with a planned, second look laparoscopy within 8-12 (+4) weeks will be enrolled. All subjects must undergo myomectomy with/without treatment of co-existing pathology e.g. (+/-) adhesions and/or (+/-) endometriosis, and/or (+/-) adenomyosis, and/or (+/-) ovarian cyst(s). The value of the second look laparoscopy (SLL) must be confirmed by the investigator to be of clinical benefit to the subject. The subject must be desirous of future fertility and willing to undergo the SLL to assess whether pathology (e.g. adnexal adhesions or endometriosis) exists which could be treated with a goal of improving their likelihood of conceiving and progressing to full term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actamax™Adhesion Barrier | Experimental | Following Myomectomy, subjects randomized to the Actamax™Adhesion Barrier Arm will have up to 30mL of product applied to all sites of surgery (area of treatment/trauma). |
|
| Surgical Control | No Intervention | Myomectomy will be performed with no adhesion barrier application. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actamax™Adhesion Barrier | Device | Actamax™Adhesion Barrier is a degradable hydrogel to be sprayed directly on surgically traumatized tissue. The aim of using the Actamax™ Adhesion Barrier (AB) in this way is to allow damaged and apposing tissue surfaces the opportunity to heal separately without becoming abnormally attached. |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion Free at Sites of Surgery at SLL | The primary efficacy outcome measure will be being adhesion free at sites of surgery throughout the whole abdominopelvic cavity at SLL. | 8-12 weeks postoperatively but out to 16 weeks where circumstances require (vacations, etc.) |
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Preoperative Inclusion Criteria:
Intraoperative Inclusion Criteria:
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:
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:
If, in the opinion of the surgeon, subject would have no clinical benefit for a SLL.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trudy D Estridge, PhD | Contact | 650-245-6561 | trudy.estridge@actamax.com |
| Name | Affiliation | Role |
|---|---|---|
| Trudy Estridge | Actamax Surgical Materials LLC | Study Director |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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