MedTrace Logo

Oxidized Cellulose hEmostAsis evaluatioN

NCT01637025 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2013-01-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some countries marketed as Tabotamp®)

Conditions

  • Intra-operative Bleeding

Interventions

DEVICE

Oxidized cellulose strip

Single use, intra-operative application to the target bleeding site

DEVICE

Oxidized regenerated cellulose strip

A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose

Sponsors & Collaborators

  • Baxter Innovations GmbH

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Edith Hantak, DVM · Baxter Innovations GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Czechia
  • Germany
  • Hungary
  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01637025 on ClinicalTrials.gov