Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy
Condition: Intrauterine Adhesions
MeSH terms: Tissue Adhesions
Intervention: Seprafilm; Sterile Saline Solution
Intervention description: Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC).; For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: submucosal myomas; intrauterine adhesions; hysteroscopic myomectomy; seprafilm

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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)