Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02244671
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2014-08-21
Brief Title:
Botulinum-assisted Orbital Fat Augmentation With PRP Platelet-rich-plasma
Sponsor:
Fox Donald Munro MD PC
Organization:
Fox Donald Munro MD PC
Study Overview
Official Title:
Botulinum-assisted Orbital Fat Augmentation With PRP Platelet-rich-plasma
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
immobilization of yoked extra-ocular muscles in the anophthalmic orbit in conjunction with platelet-rich-plasma will improve integration of viable adipocytes injected into orbital fat
Detailed Description:
Immobilization of tissue graft graft bed is a prerequisite for tissue integration Since yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat injection into the anophthalmic orbit the use of botulinum toxins can be used to prevent movement of the orbital tissue beds and improve anchoring of injected fat Platelet rich plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process This innovation builds on the results of IRB protocols 1027 and 1201 as registered with Clinical Trialsgov
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