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

Yonsei Medical Journal 2020년 61권 10호 p.868 ~ 874
이동윤, 이사라, 김슬기, 주종길, 이우선, 신중호, 조시현, 박준철, 김성훈,
소속 상세정보
이동윤 ( Lee Dong-Yun ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Obstetrics and Gynecology
이사라 ( Lee Sa-Ra ) - University of Ulsan College of Medicine Asan Medical Center Department of Obstetrics and Gynecology
김슬기 ( Kim Seul-Ki ) - Seoul National University Bundang Hospital Department of Obstetrics and Gynecology
주종길 ( Joo Jong-Kil ) - Pusan National University School of Medicine Department of Obstetrics and Gynecology
이우선 ( Lee Woo-Shun ) - Medytox Inc. Department of Dermatology
신중호 ( Shin Jung-Ho ) - Korea University College of Medicine Korea University Guro Hospital Department of Obstetrics and Gynecology
조시현 ( Cho Si-Hyun ) - Yonsei University College of Medicine Gangnam Severance Hospital Department of Obstetrics and Gynecology
박준철 ( Park Joon-Cheol ) - Keimyung University School of Medicine Department of Obstetrics and Gynecology
김성훈 ( Kim Sung-Hoon ) - University of Ulsan College of Medicine Asan Medical Center Department of Obstetrics and Gynecology

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 postoperative week 4. The post-surgery incidence of IUAs was 23.4% in the ABT13107 group and 25.8% in the comparator group; this difference met the criteria for ABT13107 to be considered as not inferior to the comparator. No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups. Most adverse events were mild in severity, and no serious adverse events occurred.

Conclusion: ABT13107, a new anti-adhesive barrier containing hyaluronic acid, was not inferior to the highly viscous hyaluronic acid anti-adhesive barrier, Hyalurobarrier® in IUA formation after hysteroscopic surgery (Clinical trial registration No. NCT 04007211).

키워드

Hysteroscopy; hyaluronic acid; infertility; tissue adhesions; uterus

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