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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 Med J. 2020 Oct; 61(10):868-874.YM

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. NCT04007211).

Authors+Show Affiliations

Department of Obstetrics & Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.Department of Obstetrics & Gynecology, Seoul National University Bundang Hospital, Seongnam, Korea.Department of Obstetrics & Gynecology, Pusan National University School of Medicine, Busan, Korea.Department of Dermatology, Medytox Inc., Seoul, Korea.Department of Obstetrics & Gynecology, Guro Hospital, College of Medicine, Korea University, Seoul, Korea.Department of Obstetrics & Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.Department of Obstetrics & Gynecology, Keimyung University School of Medicine, Daegu, Korea. jcpark@dsmc.or.kr.Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. kimsung@amc.seoul.kr.

Pub Type(s)

Equivalence Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

32975061

Citation

Lee, Dong Yun, et al. "A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions After Hysteroscopic Surgery: a Randomized, Non-Inferiority Trial." Yonsei Medical Journal, vol. 61, no. 10, 2020, pp. 868-874.
Lee DY, Lee SR, Kim SK, et al. A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial. Yonsei Med J. 2020;61(10):868-874.
Lee, D. Y., Lee, S. R., Kim, S. K., Joo, J. K., Lee, W. S., Shin, J. H., Cho, S., Park, J. C., & Kim, S. H. (2020). A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial. Yonsei Medical Journal, 61(10), 868-874. https://doi.org/10.3349/ymj.2020.61.10.868
Lee DY, et al. A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions After Hysteroscopic Surgery: a Randomized, Non-Inferiority Trial. Yonsei Med J. 2020;61(10):868-874. PubMed PMID: 32975061.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial. AU - Lee,Dong Yun, AU - Lee,Sa Ra, AU - Kim,Seul Ki, AU - Joo,Jong Kil, AU - Lee,Woo Shun, AU - Shin,Jung Ho, AU - Cho,SiHyun, AU - Park,Joon Cheol, AU - Kim,Sung Hoon, PY - 2020/06/10/received PY - 2020/08/07/revised PY - 2020/08/25/accepted PY - 2020/9/25/entrez PY - 2020/9/26/pubmed PY - 2020/10/21/medline KW - Hysteroscopy KW - hyaluronic acid KW - infertility KW - tissue adhesions KW - uterus SP - 868 EP - 874 JF - Yonsei medical journal JO - Yonsei Med J VL - 61 IS - 10 N2 - 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. NCT04007211). SN - 1976-2437 UR - https://www.unboundmedicine.com/medline/citation/32975061/A_New_Thermo_Responsive_Hyaluronic_Acid_Sol_Gel_to_Prevent_Intrauterine_Adhesions_after_Hysteroscopic_Surgery:_A_Randomized_Non_Inferiority_Trial_ L2 - https://www.eymj.org/DOIx.php?id=10.3349/ymj.2020.61.10.868 DB - PRIME DP - Unbound Medicine ER -