INTERGEL Adhesion Prevention Solution Clinical Study of Use during Laparotomy for Gynecologic Interventions Lifecore Biomedical, Inc.

9/4/01


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Table of Contents

INTERGEL Adhesion Prevention Solution Clinical Study of Use during Laparotomy for Gynecologic Interventions Lifecore Biomedical, Inc.

Outline

Adhesions

Adhesion Evaluation

American Fertility Society (AFS) Score

American Fertility Society (AFS) Score

American Fertility Society (AFS) Score

Modified American Fertility Score (mAFS)

Modified American Fertility Society Score

Retrospective American Fertility Society Score (rAFS)

Retrospective American Fertility Score Stratification

Modified American Fertility Score (mAFS) Retrospective American Fertility Score (rAFS)

Intergel

Clinical Study Objectives

Pilot Study: Summary

Pivotal Study Design

Pivotal Study Design

Pivotal Study Design

Pivotal Study Outcome Patient Accounting

Baseline Evaluation

Baseline Parameter: Race

Baseline Parameter: Mean Adhesion Evaluation

Baseline Parameter: Patients with / without Adhesiolysis

Indications for Use

likelihood of developing moderate or severe post-operative adenexal adhesions: rAFS = 11 to 32

in patients undergoing adhesiolysis or myomectomy during conservative gynecological pelvic surgery by laparotomy

adhesion reformation to sites in addition to the adenexa Reformed Adhesions at Second - Look:

adhesion formation at surgical sites Surgical Site Adhesions at Second - Look:

Safety: Infection Rate

Summary

Author: Roxolana Horbowyj