title: A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier.
abstract: OBJECTIVE
  Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery.
  
  
  METHODS
  This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL.
  
  
  RESULTS
  No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34).
  
  
  CONCLUSIONS
  Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.
authors.affiliation: Consultant in Reproductive Medicine and Surgery, Hammersmith Hospital, Du Cane Road, London, W12 0HS, UK. g.trew@imperial.ac.uk.
authors.forename: Geoffrey H
authors.initials: GH
authors.lastname: Trew
authors.affiliation: Department of Gynecological Endoscopic Surgery, Lefkos Stavros Hospital, Athens, 115 28, Greece.
authors.forename: George A
authors.initials: GA
authors.lastname: Pistofidis
authors.affiliation: Department of Gynecology and Obstetrics, University of Tübingen, Tübingen, 72076, Germany.
authors.forename: Sara Y
authors.initials: SY
authors.lastname: Brucker
authors.affiliation: Department of Gynecology and Obstetrics, University of Tübingen, Tübingen, 72076, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Krämer
authors.affiliation: Department of Obstetrics, Gynecology, and Gynecology Oncology, Pius Hospital, Oldenburg, 26121, Germany.
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Ziegler
authors.affiliation: Department of Obstetrics and Gynecology, Johanna Etienne Krankenhaus, Neuss, 41462, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Korell
authors.affiliation: Department of Obstetrics, Gynecology, and Gynecology Oncology, Pius Hospital, Oldenburg, 26121, Germany.
authors.forename: Henning
authors.initials: H
authors.lastname: Ritter
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, G12 8QQ, UK.
authors.forename: Alex
authors.initials: A
authors.lastname: McConnachie
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, G12 8QQ, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.affiliation: Corvus Communications Ltd, East Sussex, TN22 4PB, UK.
authors.forename: Alison M
authors.identifier: http://orcid.org/0000-0003-2077-1227
authors.initials: AM
authors.lastname: Crowe
authors.affiliation: Actamax Surgical Materials LLC, Wilmington, DE, 19803, USA.
authors.forename: Trudy D
authors.initials: TD
authors.lastname: Estridge
authors.affiliation: Department of Obstetrics and Gynecology, Augusta University, Augusta, GA, 30912, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
authors.affiliation: Department of Obstetrics, Gynecology, and Gynecology Oncology, Pius Hospital, Oldenburg, 26121, Germany.
authors.forename: Rudy L
authors.initials: RL
authors.lastname: De Wilde
mesh_terms: D000328:Adult; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000008:administration & dosage; D010535:Laparoscopy / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D000267:Tissue Adhesions / Q000517:prevention & control*; D063186:Uterine Myomectomy / Q000009:adverse effects
chemical_list: D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D011092:Polyethylene Glycols
keywords: Adhesion barrier study; Gynecological laparoscopic surgery; Hydrogel adhesion barrier; Post-surgical adhesions; Second-look laparoscopy