DESCRIPTION (Verbatim from the Applicant's Abstract): Adhesion formation after
abdominal surgery is a significant cause of post-operative morbidity. In
gynecological surgery, adhesions can lead to infertility, chronic pain, and
obstructive disorder. Numerous adhesion prevention adjuvant have been
investigated, most of which are based on a pharmacological agents or protective
barriers. However, no systematic studies have been conducted to determine the
combined effect of a transient barrier and pharmacological agent using a local,
controlled release system. This provided an incentive to conduct comparative
studies on controlled release systems based on unique transient barriers
containing previously tested pharmacological agents or potentially effective
ones. Phase I objective is to determine the feasibility of using gel-forming,
hyaluronic acid/calcium acetate aqueous solution and no aqueous absorbable
liquid co polyester as transient barrier matrices to control release of
pharmacologically active agents for preventing post-surgical adhesion. Phase I
plans entail (1) identifying and synthesizing fast absorbing liquid gel-forming
co-polyesters; (2) preparing and conducting comparative rheological studies on
hyaluronic acid Ca acetate (HA/CaAc) and liquid copolyesters as candidate
matrices for controlled drug release, (3) formulating, the selected (HA/CaAc)
and liquid copolyesters with selected pharmacological agents; (4) validating,
and conducting a pilot study on three rat models for evaluation of three types
of post-surgical adhesion, (5) conducting' the main study and using the results
to identify two promising formulations for a Phase II study This will entail
(1) completing a comprehensive in vivo studies using three animal species; (2)
selecting one final system and completing pertinent development and scale-up
studies; and (3) initiating the safety study.
PROPOSED COMMERCIAL APPLICATION:
Successful completion of Phase I study will provide the bases for pursuing a Phase II study
and eventual development and marketing of a unique, highly effective system for managing
key post-surgical complications associated with several procedures. This will not only
benefit patients, but also reduce the cost of healthcare.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
abdomen acetates adhesions calcium cell adhesion chemical synthesis gel hyaluronate laboratory rat nonblood rheology
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