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Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty: a Randomized Clinical Study

NCT06505252 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-17

No results posted yet for this study

Summary

This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of:

1. Evaluation of the graft uptake rate.
2. Evaluation and comparing audiological outcomes.
3. Finding out intraoperative and postoperative morbidity.

Conditions

  • Chronic Suppurative Otitis Media

Interventions

PROCEDURE

enoscopic Myringoplasty

general anesthesia. A single surgeon will perform all surgeries. * A small incision in the rim of ear lobule on the same side of the operated ear, a small piece of adipose tissue will be removed according to the experience of the surgeon. * Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle * sponge gel (Gelfoam) will pushed through TM perforation into the middle ear to support the graft and to avoid its medialization * the previously removed fat graft will be inserted through the perforation adjusted so most of the fat piece lying medial to the perforation and small part laterally in patients group A: 0.5 mL of HA vial will be injected directly over the fat graft and the TM remnant. After 5 minutes small gelfoam pieces soaked in 0.5 mL of HA vial will applied over the fat in patients group B PRPG was inserted into the external auditory canal on the outer face of the TM remnant and fat

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2026-07-09
Completion
2026-10-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505252 on ClinicalTrials.gov