A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial.

ABSTRACT:

Purpose

To investigate the efficacy and safety of a newly developed thermo-responsive sol-gel, ABT13107, for reducing the formation of intrauterine adhesions (IUAs) after hysteroscopic surgery.

Materials and methods

In this multicenter, prospective, randomized trial (Canadian Task Force classification I), 192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea were randomized into the ABT13107 group or the comparator (Hyalobarrier®) group in a 1:1 ratio. During hysteroscopic surgery, ABT13107 or Hyalobarrier® was injected to sufficiently cover the entire intrauterine cavity.

Results

The patients returned to their respective sites for safety assessments at postoperative weeks 1 and 4 and for efficacy assessments at

SUBMITTER: Lee DY 

PROVIDER: S-EPMC7515784 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature