4DryField vs. hyalobarrier gel for preventing the recurrence of intrauterine adhesions - a pilot study
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Randomized Controlled Trial, Comparative Study
- Keywords
- Asherman’s syndrome, Prevention of intrauterine adhesions, hyaluronan gel, hysteroscopic adhesiolysis, modified starch,
- MeSH
- Tissue Adhesions prevention & control MeSH
- Adult MeSH
- Gels MeSH
- Gynatresia * surgery MeSH
- Hysteroscopy * methods MeSH
- Single-Blind Method MeSH
- Hyaluronic Acid * administration & dosage MeSH
- Humans MeSH
- Uterine Diseases * prevention & control MeSH
- Pilot Projects MeSH
- Surveys and Questionnaires MeSH
- Recurrence MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Gels MeSH
- Hyaluronic Acid * MeSH
INTRODUCTION: This was a single-center pilot study that sought to describe an innovative use of 4DryField® PH (premix) for preventing the recurrence of intrauterine adhesions (IUAs) after hysteroscopic adhesiolysis in patients with Asherman's syndrome (AS). MATERIAL AND METHODS: Twenty-three patients with AS were enrolled and 20 were randomized (1:1 ratio) to intrauterine application of 4DryField® PH (n = 10) or Hyalobarrier® gel (n = 10) in a single-blind manner. We evaluated IUAs (American Fertility Society [AFS] score) during initial hysteroscopy and second-look hysteroscopy one month later. Patients completed a follow-up symptoms questionnaire three and reproductive outcomes questionnaire six months later. RESULTS: The demographic and clinical characteristics, as well as severity of IUAs, were comparable in both groups. The mean initial AFS score was 9 and 8.5 in the 4DryField® PH and Hyalobarrier® gel groups, respectively (p = .476). There were no between-group differences in AFS progress (5.9 vs. 5.6, p = .675), need for secondary adhesiolysis (7 vs. 7 patients, p = 1), and the follow-up outcomes. CONCLUSION: 4DryField® PH could be a promising antiadhesive agent for preventing the recurrence of IUAs, showing similar effectiveness and safety to Hyalobarrier® gel. Our findings warrant prospective validation in a larger clinical trial. CLINICAL TRIAL REGISTRY NUMBER: ISRCTN15630617.
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