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

ConditionChronic Suppurative Otitis Media
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-50
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with central small or median sized dry perforation

Aged between 14 and 50 years

In cases of CSOM the perforation must be dry with no otorrhea with healthy middle ear mucosa for at least three month without medications

Conductive gap on audiometry not more than 40 dB.

Disqualifiers

Discharging CSOM .

Concurrent URTI .

CSOM with dry marginal perforation

Patients who didn't come for follow up.

Trial design

Design model

Parallel

Treatments tested in this trial

  • enoscopic Myringoplasty

    Procedure/Surgery

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: HA group or group AExperimental treatment 1 intervention
Group B: PRP group or group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

graft taking

Endoscopic examination of TM: Graft will considered as successfully taken if there is no residual TM perforation after 3 months postoperativly.

Time frame
3 months

Secondary outcomes

1

Audiotympanogram

effect on hearing by using Audiotympanogram will be done three months post-operative

Time frame
3 months
2

Otorrhea

presence or absence of otorrhea by history and ear examination

Time frame
1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: