An interventional study of enoscopic Myringoplasty in Chronic Suppurative Otitis Media, sponsored by Assiut University. Not yet recruiting. Open to participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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:
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 .
53 studies on the registry are indexed under Tympanic Membrane Perforation; 14 are open to participants now.
This study's planned enrollment of 60 is close to the median of 57 across 39 interventional studies indexed under Tympanic Membrane Perforation.
Browse Tympanic Membrane Perforation studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
* 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
* 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
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
graft taking
Endoscopic examination of TM: Graft will considered as successfully taken if there is no residual TM perforation after 3 months postoperativly.
Time frame: 3 months
Audiotympanogram
effect on hearing by using Audiotympanogram will be done three months post-operative
Time frame: 3 months
Otorrhea
presence or absence of otorrhea by history and ear examination
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Tympanic Membrane Perforation →