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Evaluation of SprayShield™ Adhesion Barrier in a single center: randomized controlled study in 15 women undergoing reconstructive surgery after laparoscopic myomectomy

  • General Gynecology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Objective

The objective of this study was to evaluate the safety and efficacy of SprayShield™ Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery.

Design

This was a prospective, controlled, blinded, and randomized study. Patient blinding was performed intraoperatively. Subjects were randomly assigned to the SprayShield™ or the control group in a 2:1 ratio.

Setting

The study was conducted at the Clinic of Gynaecology and Obstetrics, at the University Hospital for Gynecology in Germany.

Patients

Fifteen patients participated in this study; nine patients were assigned to the SprayShield™ and six patients to the control group.

Interventions

During first operation (FLL) in the SprayShield™ group, the agent was applied to all myomectomy suture lines. Patients in the control group did not receive any anti-adhesion treatment, only good surgical practice. A second-look laparoscopy (SLL) was performed 8–12 weeks after myomectomy to evaluate adhesion formation.

Main outcome measures

Main outcome measures were incidence, severity, and extent of uterine adhesions.

Results

No significant differences were found between the two study groups.

Conclusions

SprayShield™ is easy to use. No serious adverse event related to SprayShield™ was observed. Efficacy data are inconclusive regarding the performance of SprayShield™. Further studies are needed to better understand this performance.

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Acknowledgments

This study was sponsored by Covidien.

Conflict of interest

None.

Author information

Authors and Affiliations

  1. Klinik für Minimal Invasive Chirurgie, 14129, Berlin-Zehlendorf, Germany

    Garri Tchartchian & Bernd Bojahr

  2. Zentrum für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Gießen und Marburg GmbH, 35392, Giessen, Germany

    Andreas Hackethal

  3. Clinic of Gynecology, Obstetrics and Gynecological Oncology, University Hospital for Gynecology, School of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Pius-Hospital, Georgstreet 12, 26121, Oldenburg, Lower Saxony, Germany

    Anja Herrmann & Rudy Leon De Wilde

  4. Abteilung für Geburtshilfe und Gynäkologie, TU München, 81675, Munich, Germany

    Christian Wallwiener

  5. Universitätsklinikum Greifswald Klinik für Frauenheilkunde und Brustzentrum, 17489, Greifswald, Germany

    Ralf Ohlinger

  6. Deutsches Endometriosezentrum Berlin, Vivantes Humboldt-Klinikum, 13509, Berlin, Germany

    Andreas D. Ebert

Authors
  1. Garri Tchartchian
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  2. Andreas Hackethal
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  3. Anja Herrmann
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  4. Bernd Bojahr
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  5. Christian Wallwiener
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  6. Ralf Ohlinger
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  7. Andreas D. Ebert
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  8. Rudy Leon De Wilde
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Corresponding author

Correspondence to Rudy Leon De Wilde.

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Tchartchian, G., Hackethal, A., Herrmann, A. et al. Evaluation of SprayShield™ Adhesion Barrier in a single center: randomized controlled study in 15 women undergoing reconstructive surgery after laparoscopic myomectomy. Arch Gynecol Obstet 290, 697–704 (2014). https://doi.org/10.1007/s00404-014-3251-3

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  • DOI: https://doi.org/10.1007/s00404-014-3251-3

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