NCT01632202: Seprafilm

The Role of Seprafilm Bioresorbable Slurry in the Prevention of Intrauterine Synechiae in Patients Undergoing Hysteroscopic Myomectomy

Terminated Phase 4 Results posted Last updated 10 November 2020

What this trial tests

Phase 4 trial testing Seprafilm in Intrauterine Adhesions in 11 participants. Terminated before completion.

Timeline

1 May 2012

Primary endpoint
1 January 2014

1 January 2014

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	11
Start date	1 May 2012
Primary completion	1 January 2014
Estimated completion	1 January 2014
Sites	2 locations across United States

Drugs / interventions tested

• Seprafilm — full drug profile →
• Sterile Saline Solution

Conditions studied

• Intrauterine Adhesions — all drugs for Intrauterine Adhesions →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 18 to 48, female only, with Intrauterine Adhesions. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Presence of Iatrogenic Intrauterine Adhesions
  Time frame: 2- 3 months after surgery
  Number of Subjects with iatrogenic intrauterine adhesions. Evidence of uterine scarring will be evaluated by a 3D sonohysterogram. A 3D sonohysterogram will be performed in the standard fashion in our ultrasound department by a blinded practitioner. The degree of adhesive disease will be scored by standard convention as: * Absent Adhesive Disease: no presence of intrauterine adhesions * Mild Adh

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Biomaterializing the advances in uterine tissue engineering.
   Wei Z, Hu Y, He X, Ling W, et al · · 2022 · cited 13× · PMID 36536678 · DOI 10.1016/j.isci.2022.105657