Trials / Completed
CompletedNCT04415606
QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
A Pre-Market, Prospective, Controlled, Multicenter, Single Blinded, Pivotal Clinical Investigation of QuikClot Control+ for Use in Mild to Moderate Bleeding
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 266 (actual)
- Sponsor
- Z-Medica · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
QuikClot Control+ Hemostatic Dressing (QuikClot+) is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV Bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. QuikClot Control+ is also indicated for temporary control of mild to moderate bleeding in cardiac surgical procedures. QuikClot Control+ is also indicated for use to control bleeding from bone surface following sternotomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | QuikClot Control+ | Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin. |
Timeline
- Start date
- 2020-06-11
- Primary completion
- 2021-10-30
- Completion
- 2021-10-30
- First posted
- 2020-06-04
- Last updated
- 2022-04-04
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04415606. Inclusion in this directory is not an endorsement.