title: Intercoat gel (oxiplex): efficacy, safety, and tissue response in a laparoscopic mouse model.
abstract: OBJECTIVE
  To study the efficacy and safety of Intercoat gel in a laparoscopic mouse model with pneumoperitoneum-enhanced adhesion formation.
  
  
  METHODS
  Randomized controlled trial. Evidence obtained from a properly designed, randomized, controlled trial (Canadian Task Force classification I).
  
  
  METHODS
  University laboratory research center.
  
  
  METHODS
  Balb\c female mice 9 to 10 weeks old.
  
  
  METHODS
  Two laparoscopic mouse models for adhesion formation were used. In the first model, adhesions following bipolar opposing lesions in the pelvis were enhanced by 60 minutes of carbon-dioxide pneumoperitoneum. In the second model, adhesions were further enhanced by bowel manipulation. The first experiment evaluated the efficacy of Intercoat in both models. The second experiment evaluated the efficacy of Intercoat in the first model, when applied immediately on the lesion, when applied at the end of the pneumoperitoneum, and when applied in the upper abdomen. Biopsy specimens were taken after 7 days and were evaluated after hematoxylin-eosin and CD45 staining.
  
  
  RESULTS
  Qualitative and quantitative adhesion scoring. Morphology was evaluated by standard light microscopy. In both models, Intercoat decreased adhesion formation whether applied immediately on the lesion or at the end of the pneumoperitoneum (qualitative and quantitative scoring p <.0001 and p <.0001, respectively). Intercoat application is associated with tissue redness, vascular congestion, and cellular edema but without an inflammatory reaction. Applied in the upper abdomen, Intercoat does not increase adhesions, but decreases adhesions at higher doses (p =.0024). Intercoat in high doses had a toxic effect (p =.0058).
  
  
  CONCLUSIONS
  Intercoat is an effective antiadhesion product. It is associated with tissue edema and vasodilatation as observed after 7 days both macroscopically and by histology.
authors.affiliation: Departments of Obstetrics and Gynecology at University Hospital Leuven, Belgium. ronschonman@gmail.com
authors.forename: Ron
authors.initials: R
authors.lastname: Schonman
authors.forename: Roberta
authors.initials: R
authors.lastname: Corona
authors.forename: Adriana
authors.initials: A
authors.lastname: Bastidas
authors.forename: Carlo
authors.initials: C
authors.lastname: De Cicco
authors.forename: Karina
authors.initials: K
authors.lastname: Mailova
authors.forename: Philippe Robert
authors.initials: PR
authors.lastname: Koninckx
mesh_terms: D000818:Animals; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005782:Gels / Q000008:administration & dosage / Q000009:adverse effects; D010535:Laparoscopy / Q000009:adverse effects*; D051379:Mice; D008807:Mice, Inbred BALB C; D009852:Omentum / Q000473:pathology / Q000601:surgery; D011028:Pneumoperitoneum, Artificial / Q000009:adverse effects*; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D020011:Protective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000267:Tissue Adhesions / Q000473:pathology / Q000517:prevention & control*; D014945:Wound Healing
chemical_list: D005782:Gels; C406630:Oxiplex; D020011:Protective Agents; D011092:Polyethylene Glycols; D002482:Cellulose