Clinical Research Details

Clinical Research

Study of BD ORC Original Absorbable Hemostat vs. Surgicel® Original Absorbable Hemostat

Study Description

This study will evaluate the safety and efficacy of BD ORC Original Absorbable Hemostat when compared to a currently marketed ORC hemostat (Surgicel® Original Absorbable Hemostat) for achieving hemostasis at target bleeding sites (TBSs) as an adjunctive hemostat in planned, open/minimally invasive general surgical procedures

Inclusion/Exclusion Criteria

Inclusion Criteria:

1. Males or females 22 years of age or older at the time of consent

2. Is undergoing a planned open/minimally invasive surgical procedure in general surgery

Exclusion Criteria:

1. Is known to be pregnant or plans to become pregnant during the study period

2. Has an uncontrolled bleeding disorder

3. Has a documented clinical history of bleeding or coagulation disorder or disease

4. Has received hemodialysis within 30 days before surgery or is planned to receive
hemodialysis within 45 days post-surgery

5. Has documented severe congenital or acquired immunodeficiency or is currently
being treated with immunosuppressive drugs

6. Has been treated or is planning to be treated with another investigational drug or
device within 30 days of surgery

7. Has taken blood thinners or chronic steroids

Open Enrollment

Contact Name: Tatiana Elias-Grajeda
Contact Phone: (904) 244-9687
Contact Email: tatiana.elias-grajeda@jax.ufl.edu

Investigators