Clinical trial NCT06505252: Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty: a Randomized Clinical Study
Official title: Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Suppurative Otitis Media
Keywords: CSOM
chronic suppurative otitis media
tympanic membrane perforation
TM perforation
myringoplasty
tympanoplasty
endoscopic tympanoplasty
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

Detailed 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 .

Eligibility criteria: 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 \&gt; 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.

Primary outcomes:
measure: graft taking
timeFrame: 3 months
Secondary outcomes:
measure: Audiotympanogram
timeFrame: 3 months
measure: Otorrhea
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.