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

NCT06505252 | Not Yet Recruiting DMC

• 1 other identifier: Endoscopic fat Myringoplasty
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Suppurative Otitis Media

Keywords

CSOM; chronic suppurative otitis media; tympanic membrane perforation; TM perforation; myringoplasty; tympanoplasty; endoscopic tympanoplasty

Outcome Measures

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.

  3 months

Secondary Outcomes (2)

• Audiotympanogram

  3 months

• Otorrhea

  1 month

Study Arms (2)

HA group or group A

EXPERIMENTAL

* 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.

Procedure: enoscopic Myringoplasty

PRP group or group B

EXPERIMENTAL

* 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

Procedure: enoscopic Myringoplasty

Interventions

enoscopic Myringoplasty PROCEDURE

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

HA group or group A; PRP group or group B

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• El-Anwar MW, El-Ahl MA, Zidan AA, Yacoup MA. Topical use of autologous platelet rich plasma in myringoplasty. Auris Nasus Larynx. 2015 Oct;42(5):365-8. doi: 10.1016/j.anl.2015.02.016. Epub 2015 Mar 17.

  PMID: 25794691 BACKGROUND

• Knutsson J, Kahlin A, von Unge M. Clinical and audiological short-term and long-term outcomes of fat graft myringoplasty. Acta Otolaryngol. 2017 Sep;137(9):940-944. doi: 10.1080/00016489.2017.1326063. Epub 2017 May 24.

  PMID: 28537107 BACKGROUND

• Kim HC, Park KS, Yang HC, Jang CH. Surgical results and factors affecting outcome in patients with fat-graft myringoplasty. Ear Nose Throat J. 2024 Jul;103(7):442-446. doi: 10.1177/01455613211063243. Epub 2021 Dec 9.

  PMID: 34881650 BACKGROUND

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Central Study Contacts

Ahmed Gamal Ahmed Gamal Abdel-Hameed, Assistant lecture

CONTACT

00201063211000; jamal1991989@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecture of otolaryngeology

Model Details: Patients will be randomly allocated to two groups: By using an online research randomizer (http://www.randomizer.org), patients will be randomly allocated to two groups Group (A): will do endoscopic myringoplasty using fat graft augmented by hylourinic acid Group (B): will do endoscopic myringoplasty using fat graft with PRP

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 17, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share