TY - JOUR
T1 - Reduction of adhesion formation by postoperative administration of ionically cross-linked hyaluronic acid
AU - Johns, Douglas B.
AU - Kiorpes, Timothy C.
AU - Rodgers, Kathleen E.
AU - Dizerega, Gere S.
AU - Donahue, William D.
PY - 1997/7
Y1 - 1997/7
N2 - 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 formulations 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 showed 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.
AB - 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 formulations 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 showed 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.
KW - Adhesion prevention
KW - LUBRICOAT
KW - hyaluronic
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U2 - 10.1016/S0015-0282(97)81472-0
DO - 10.1016/S0015-0282(97)81472-0
M3 - Article
C2 - 9207581
AN - SCOPUS:0343306721
SN - 0015-0282
VL - 68
SP - 37
EP - 42
JO - Fertility and Sterility
JF - Fertility and Sterility
IS - 1
ER -