Clinical Research Details

Study of BD ORC Original Absorbable Hemostat Compared with Surgicel® Original Absorbable Hemostat

Study Description

The purpose of this study is to 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 procedures.

Inclusion/Exclusion Criteria

Inclusion criteria: 

1) 22 years of age or older at the time of consent

2) Undergoing a planned open/minimally invasive surgical procedure (urology)

3) Agrees to comply with all study procedures and to be available for the duration of the study

4) Provision of signed and dated informed consent form

Exclusion Criteria:

1) ASA Class IV Score or Higher

2) Pregnant or plans to become pregnant during the study period

3) Has an uncontrolled bleeding disorder

4) Has a documented clinical history of bleeding or coagulation disorder or disease

5) Has taken exclusionary concomitant medications (blood thinners or chronic steroids)

6) Has a known or suspected hypersensitivity to oxidized cellulose or ORC

Open Enrollment

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

Investigators