Chronic Suppurative Otitis Media
Conditions
Keywords
CSOM, chronic suppurative otitis media, tympanic membrane perforation, TM perforation, myringoplasty, tympanoplasty, endoscopic tympanoplasty
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 .
Interventions
PROCEDUREenoscopic 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
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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
Eligibility
Sex/Gender
ALL
Age
14 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| graft taking | 3 months | Endoscopic examination of TM: Graft will considered as successfully taken if there is no residual TM perforation after 3 months postoperativly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Audiotympanogram | 3 months | effect on hearing by using Audiotympanogram will be done three months post-operative |
| Otorrhea | 1 month | presence or absence of otorrhea by history and ear examination |
Contacts
Primary ContactAhmed Gamal Ahmed Gamal Abdel-Hameed, Assistant lecture
Outcome results
None listed