Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505252
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty a Randomized Clinical Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 91Many 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 plasmaPRP 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
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 91Many 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 plasmaPRP 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None