Skip to content

Intraoperative bleeding control with thrombin-gelatin-matrix (Floseal) in advanced gynecologic surgery. A case-control study with special focus on hemostasis in patients with primary or secondary coagulapathies.

Intraoperative bleeding control with thrombin-gelatin-matrix (Floseal) in advanced gynecologic surgery. A case-control study with special focus on hemostasis in patients with primary or secondary coagulapathies.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00004903
Enrollment
200
Registered
2013-05-06
Start date
2012-05-11
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D62 T81.0

Interventions

Group 1: Patients with intraoperative bleeding WITH application of the thrombin-gelatin matrix (Floseal®, Baxter). Retrospective data collection on blood loss and inflammatory response, need for trans

Sponsors

St. Josefskrankenhaus
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Intraoperative bleeding with actual or anticipated blood loss> 1 liter 2. Extensive suergery defined as: "basic operation" (eg, hysterectomy) plus at least one of the following steps: a) lymphadenectomy, b) retropertitoneal preparation, c) peritonectomy, d) operative haemostasis in parenchymal organs 3. Alternative to item 2: Acute bleeding complications requiring operative revision 4. Application only in accordance with the instructions and within the indication

Exclusion criteria

Exclusion criteria: One of the inclusion criteria not fulfilled

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss. Evaluation of postoperative Hb-drop and need for transfusions.

Secondary

MeasureTime frame
Duration of surgery, hospital stay and ICU stay in patients with and without Floseal use. Comparison of the inflammatory response by maximum postoperative CRP increase. Comparison of revision surgeries in patients with and without Floseal use.

Countries

Germany

Contacts

Public ContactRafal Watrowski

St. Josefskrankenhaus

Rafal.Watrowski@rkk-klinikum.de+49761-27115150

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026