Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy

Exclusion Criteria

• •1. History of Human Immunodeficiency Virus (HIV)
• •2. History of Hepatitis C
• •3. History of diabetes that, in the opinion of the investigator, may delay healing
• •4. Current use of systemic corticosteroids
• •5. Active infection of genitals, vagina, cervix, uterus or urinary tract
• •6. Active bacteremia, sepsis or other active systemic infection
• •7. Presence of Sexually Transmitted Infection (STI)
• •8. Evidence of pelvic inflammatory disease (PID)
• •9. Known clotting defects or bleeding disorders
• •10. Hemoglobin \< 8 g/dL
• •11. Metastatic disease
• •12. On anticoagulant therapy
• •13. Participation in another interventional trial
• •14. Pregnancy
• •15. Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing
• •16. Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing
• •17. Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
• •18. Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
• •19. Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
• •20. Intra-operative: Cases requiring conversion to laparotomy prior to study intervention