Study objective: To study the efficacy and safety of Intercoat gel in a laparoscopic mouse model with pneumoperitoneum-enhanced adhesion formation.
Design: Randomized controlled trial. Evidence obtained from a properly designed, randomized, controlled trial (Canadian Task Force classification I).
Setting: University laboratory research center.
Subjects: Balb\c female mice 9 to 10 weeks old.
Interventions: 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.
Measurements and main 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).
Conclusion: Intercoat is an effective antiadhesion product. It is associated with tissue edema and vasodilatation as observed after 7 days both macroscopically and by histology.