Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07893418
NA

Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty

Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate the success rate of revision surgery using a conchal cartilage graft supported with autologous platelet-rich fibrin (PRF), performed under local anesthesia, in patients who previously underwent cartilage tympanoplasty and later developed a recurrent perforation of the graft requiring revision surgery. In this single-arm prospective study, the perforation will be repaired with a cartilage graft harvested from the concha of the same (previously operated) ear. Both surfaces of the graft will be covered with PRF obtained from the patient's own blood. Patients can be discharged on the same day without systemic antibiotics. The primary outcome is anatomical success, defined as graft integrity and closure of the perforation. Secondary outcomes include hearing results (air-conduction thresholds and air-bone gap), quality of life (COMQ-12), postoperative pain (VAS), paracetamol use, change in perforation size, complications and operative time. Patients will be followed for 6 months after surgery. A total of 35 patients are planned to be enrolled.

Official title: An Innovative Approach In Revision Cartilage Tympanoplasty: A Prospective Study With Platelet-Rich Fibrin (PRF) Support

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2026-02-15

Completion Date

2027-02-01

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

PROCEDURE

PRF-supported conchal cartilage tympanoplasty under local anesthesia

Revision tympanoplasty performed under local anesthesia (lidocaine hydrochloride with epinephrine, diluted 1:1, infiltrated into the external auditory canal and conchal region). Perforation size is measured intraoperatively, and a conchal cartilage graft harvested from the ipsilateral (previously operated) ear is shaped accordingly. The graft is supported on both its medial and lateral surfaces with autologous platelet-rich fibrin obtained by centrifugation of 9 mL of the patient's venous blood, and the perforation is repaired. No additional biomaterials or chemical agents are used.

Locations (1)

University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Bakırköy, Turkey (Türkiye)