Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Intrauterine Adhesions

In brief

Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repair process takes place. When used in the abdominopelvic cavity, it has been shown to reduce the incidence of adhesions. The intrauterine cavity is a potential space where the walls of the uterus are collapsed upon itself in the normal state. It has been demonstrated that the trauma of removing a submucosal fibroid with electrocautery exposes the uterus to great potential for intrauterine adhesions since the raw charred surface is directly opposed to the opposite endometrial surface. Previous studies have shown that the placement of hyaluronic acid in the intrauterine cavity after a myomectomy is not only safe, but also decreases the incidence of intrauterine adhesions. The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that they will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, the investigators anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.

Key facts

Study ID

NCT01632202

Run by

Weill Medical College of Cornell University

People needed

11

Starts

2012-05-01

Expected to finish

2014-01-01

Last updated by the study team

2020-12-03

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Reproductive aged women: Age 18-48 years old
• Non-pregnant
• Otherwise healthy
• Regular menstrual cycle
• Documented submucosal myomas (one or more)
• Undergoing hysteroscopic myomectomy
• Patients must have signed an informed consent.

You may not qualify if…

• Age < 18 or in menopause
• Undergoing a second uterine surgical procedure
• Other significant uterine pathology (including but not limited to adhesions, septae, or cancerous lesions)
• Hysteroscopic evidence of synechiae at the time of the procedure
• Surgeries complicated by excessive bleeding; defined by estimated blood loss > 100cc given that the presence of excessive bleeding may predispose a patient to the formation of intrauterine adhesions
• Surgeries complicated by uterine perforation
• Surgeries complicated by postoperative intrauterine infection given that infection may predispose a patient to the formation of intrauterine adhesions (If these patients received Seprafilm Slurry, they will continue to be followed for safety monitoring)

Where it is running

• Weill Medical College of Cornell University — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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