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Clinical Trial of Collagen-Based Bone Repair Materials for the Repair of Mastoid Cavity Remnants

Application of Collagen-Based Bone Repair Materials in Repairing the Surgical Cavity After Mastoidectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111473
Enrollment
Unknown
Registered
2025-10-31
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Bone defect in the parotid surgical cavity

Interventions

Collagen-Based Bone Repair Material for Mastoid Repair Group:Application of Collagen-Based Bone Repair Material on Mastoid Repair

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients requiring mastoidectomy for chronic otitis media, cholesteatoma, or temporal bone tumours; 2. Cases with significant residual mastoid cavity necessitating mastoid packing to eliminate residual cavity and reconstruct the external auditory canal; 3. Age range: 18 to 70 years; 4. Patients able to attend one-year postoperative follow-up appointments.

Exclusion criteria

Exclusion criteria: 1.Patients with severe systemic diseases that are poorly controlled, such as autoimmune diseases, hematological diseases, diabetes mellitus, etc; 2.Patients with severe local conditions that make mastoid obliteration inappropriate; 3.Unable to cooperate with follow-up;

Design outcomes

Primary

MeasureTime frame
The osteogenesis of the surgical cavity was evaluated based on temporal bone CT results, including the ratio of the volume of newly formed bone to the volume of the mastoid surgical cavity after surge;

Secondary

MeasureTime frame
Score of the Chronic Otitis Media Survey (COMS);Time to Dry Ear;Time to complete epithelialization of the external auditory canal;Cranioauricular Angle;Periauricular Sensation Score(VAS);Presence of Postauricular Tissue Collapse;

Countries

China

Contacts

Public ContactGuodong Feng

Peking Union Medical College Hospital

fengguodong2013@163.com+86 10 69156313

Outcome results

None listed

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