Oxidized, regenerated cellulose and porcine collagen (ORC-Coll) in neurosurgery versus collagen-bound fibrin sealant (CBFS): a single blind, prospective, randomized controlled noninferiority trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039632

Enrollment

110

Registered

2026-03-19

Start date

2025-03-20

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

C71 D32 D35.0 I67.1 G96.0

Interventions

Group 1: A single-blinded, prospective, monocentric, randomized controlled interventional trial over seventeen months was conducted, including patients requiring duraplasty during spinal or cranial pr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients who require duraplasty during the surgical procedure and have provided informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: no consent.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the occurrence of cerebrospinal fluid (CSF) fistulas immediately after surgery as well as during follow-up within the first 6 months postoperatively.	—

Secondary

Measure	Time frame
the secondary endpoint is the occurrence of impaired wound healing and wound infections, assessed on the basis of clinical findings and, where applicable, imaging findings (documented in the inpatient and outpatient medical records).	—

Countries

Germany

Contacts

Public ContactStefan Linsler

Klinik für Neurochirurgie MCO der FAU Bayreuth

stefan.linsler@fau.de0921 400 754202

Outcome results

None listed

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