NCT03654560

Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: United Health Products, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.

Detailed description

This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare HemoStyp with Surgicel® in the management of bleeding during surgery.

Conditions

• Hemostasis
• Bleeding

Interventions

Type	Name	Description
DEVICE	HemoStyp	During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
DEVICE	Surgicel	During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.

Timeline

• Start date: 2018-12-28
• Primary completion: 2019-08-05
• Completion: 2019-09-12
• First posted: 2018-08-31
• Last updated: 2020-10-22
• Results posted: 2020-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study