Trials / Completed
CompletedNCT01637025
Oxidized Cellulose hEmostAsis evaluatioN
A Prospective, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Traumastem as an Adjunct to Hemostasis for Tissue Bleeding in Open Cardiac, Intra-abdominal (Including Retroperitoneal) and Pelvic Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Baxter Healthcare Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2012-07-10
- Last updated
- 2013-01-24
Locations
24 sites across 4 countries: Czechia, Germany, Hungary, Poland
Source: ClinicalTrials.gov record NCT01637025. Inclusion in this directory is not an endorsement.