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
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