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

Assiut University

Status: Not yet enrolling

Conditions: Chronic Suppurative Otitis Media

Treatments: Procedure: enoscopic Myringoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06505252

Endoscopic fat Myringoplasty

Details and patient eligibility

About

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.

Full description

Tympanic membrane (TM) perforations result in recurrent middle ear infection and hearing loss. Both these hazards can be prevented by the reconstructive surgery of the tympanic membrane.

Fat graft myringoplasty (FGM) has been reported as a suitable procedure to close long-standing TM perforations FGM is an efficient, safe and potentially fast method for TM perforation repairing with a success rate varies from 79% to 91%..Many researches was done to use supporting material in myringoplasty Saliba et al used hyaluronic acid fat graft myringoplasty [HAFGM] and results in a higher success rate than using FGM alone. El-Anwar et al proved that Topical autologous platelet-rich plasma(PRP) application during myringolpasty is safe, efficient and enhances healing of TM perforation PRP includes many autologous growth factors that have significant functions like cell proliferation, migration, and angiogenesis. Fibrin and fibronectin are essential proteins in PRP that provide the structural support needed for the cell migration, cell proliferation, and 3-dimensional growth of tissues.

HA has been shown to play a role in cellular signaling, leukocyte growth and migration, Cell adhesion and biological remodeling and is mainly involved in tissue healing with a central role in modulating inflammatory responses also, Its absorption of water causes expansion in volume and formation of a viscoelastic gel which constitutes a favorable scaffold for tissue regeneration and remodeling .

Enrollment: 60 estimated patients

Sex: All

Ages: 14 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Discharging CSOM .
• Concurrent URTI .
• CSOM with dry marginal perforation
• Patients who didn't come for follow up.
• Age less than 14 or more than 50.
• Unsafe CSOM with cholesteatoma, apparent retraction pockets, granulations, or extensive myringosclerosis reaching the edges of the perforation. Patients
• Patients who are suspected of having Eustachian tube dysfunction.
• Suspected ossicular pathology in safe CSOM if the ABG > 40dB.
• Patients with history of Previous ear surgery.
• Patients unfit for surgery or having chronic medical illness.
• Narrow external auditory canal.
• Patients who refused to enrolled in our study
• Patients with sensorineural hearing loss or only functioning ear.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

HA group or group A

Experimental group

Description:

* All patients underwent operations under 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. * The incision will be closed with vicryl 4/0 sutures. * Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle or sickle knife. * 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. HA was used in liquid form, using a 2 mL vial (® Hyalgan) containing 20 mg of sodium hyaluronate that is synthesized by fermentation. The vial will be prepared for direct injection.

Treatment:

Procedure: enoscopic Myringoplasty

PRP group or group B

Experimental group

Description:

* All patients underwent operations under 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. * The incision will be closed with vicryl 4/0 sutures. * Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle or sickle knife. * 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 PRPG was inserted into the external auditory canal (EAC) on the outer face of the TM remnant and fat graft. Special attention will be given to obtaining close contact among the PRPG, TM, and fat graft. The

Treatment:

Procedure: enoscopic Myringoplasty