NCT06505252

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

Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 14 Years – 50 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Chronic Suppurative Otitis Media

Interventions

Type	Name	Description
PROCEDURE	enoscopic 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

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-07-09
• Completion: 2026-10-10
• First posted: 2024-07-17
• Last updated: 2024-07-17