Investigation of the occurence of tubelike passages between the nasal and oral cavity using a sealant patch in primary palatoplasty of patients with cleft lip and palate

Occurence of Oronasal Fistulas (ONF) using a fibrin sealant patch in primary palatoplasty

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004130-28-DE

Enrollment

Registered

2018-03-13

Start date

2018-07-25

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Cleft lip and palate MedDRA version: 20.1 Level: PT Classification code 10009260 Term: Cleft lip and palate System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: TachoSil Pharmaceutical Form: Sealant matrix INN or Proposed INN: Human Thrombin CAS Number: 9002-04-4 Other descriptive name: HUMAN THROMBIN Concentration unit: IU international unit(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: Testing the compatibility and safety of TachoSil® in children with continuous cleft lip and palate or isolated combined hard and soft palate;Secondary Objective: Estimation of the frequency of occurrence of postoperative fistulas, wound healing disorders and food regurgitations;Primary end point(s):	—

Countries

Germany

Contacts

Public ContactDr. rer. nat. Anne Schellenberg

Studienzentrale SZB

anne.schellenberg@ukbonn.de004922828713939

Outcome results

None listed

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