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Reduction of adhesion formation by postoperative administration of ionically cross-linked hyaluronic acid
D B Johns1, K E Rodgers, W D Donahue
1Ethicon Inc., Somerville, New Jersey 08876-0151, USA.
Objective:
To examine the efficacy of various formulations of hyaluronic acid (HA), including HA ionically cross-linked with trivalent iron, in animal models of adhesion formation.
Design:
Hyaluronic acid formulation of varying concentrations and cross-linked densities were prepared and evaluated in a rabbit uterine horn model and a rabbit sidewall model.
Setting:
ETHICON, Inc., Somerville, New Jersey.
Subject(S):
New Zealand White rabbits.
Intervention(S):
Test formulations were applied as intraperitoneal instillates after surgery.
Main Outcome Measure(S):
Adhesion formation was assessed at 7 and 14 days (sidewall and uterine horn model, respectively).
Result(S):
Hyaluronic acid that was not ionically cross-linked was ineffective in reducing adhesions in these models even at high viscosity, whereas the ionically cross-linked formulations of HA with trivalent iron were highly effective. Efficacy improved with increased levels of ionic cross-linking. Flowable gels, which could be delivered readily by syringe and cannula, also were effective when administered at a site remote from injury and with saline present.
Conclusion(S):
Whereas previous studies show that HA was effective in reducing adhesions peripheral to the site of injury, HA ionically cross-linked with trivalent iron was effective in reducing adhesions at all sites. From these studies, a formulation of HA ionically cross-linked with trivalent iron, 0.5% Ferric Hyaluronate Gel (LUBRICOAT; ETHICON, Inc., Somerville, NJ), was identified for subsequent clinical evaluations.