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The use of modified collagene membranes compared to PDS foils in orbital floor fractures

The use of modified collagene membranes compared to PDS foils in orbital floor fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010809
Enrollment
80
Registered
2016-08-15
Start date
2016-10-01
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

S02.3 S02.4

Interventions

Group 1: Reconstruction of orbital floor fracture with PDS foils as Standard treatment Group 2: Reconstruction of orbital floor fractures with collagene membranes (3 different types) as test Group, ea

Sponsors

Universitätsklinikum Schleswig-Holstein Campus Kiel
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: isolated orbitalfloor fractures fractures of the cheek bone

Exclusion criteria

Exclusion criteria: not interested in participation younger than 18 years dementia large fracture with Need of titanium mesh reconstruction

Design outcomes

Primary

MeasureTime frame
The Primary outcome will be reached after 12 month post operationem. In an standardized department specific Investigation bow diplopiae, paresthesia and esthetic probelms will be evaluated.

Secondary

MeasureTime frame
Infection and Revision of the orbital floor reconstruction

Countries

Germany

Contacts

Public ContactFalk Birkenfeld

UKSH, Campus Kiel, MKG-Chirurgie

f.birkenfeld@mkg.uni-kiel.de01719611833

Outcome results

None listed

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