Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05401370
Status:
UNKNOWN
Last Update Posted:
2022-06-02
First Post:
2022-04-25
Brief Title:
Role of Methylene Blue in Parotid Surgery
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Role of Methylene Blue Dye in Identification of Facial Nerve in Parotid Surgery
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
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:
usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery
Detailed Description:
The specific surgical morbidity remains significant in parotid gland surgery In addition to temporary facial weakness and permanent facial nerve injury postparotidectomy depression and Freys syndrome gustatory sweating are specific for this type of surgery To reduce the surgical morbidity several modifications of parotidectomy have been implemented but postsurgical complications remain especially facial nerve injury To overcome this difficulty an identification method might be used such as preoperative intravital staining of the gland with methylene blue MB
Although MB staining is not designed to be used as a sole technique it can be combined with other techniques such as identification of the anatomic landmarks MB staining is simple inexpensive and not time consuming techniqueIt is an indirect facial nerve identification technique because there is no nerve handlingthus decreasing iatrogenic nerve impairmentAfter injection of the parotid gland with MB dye fine white nerve fibers can be observed Tumors in the parotid gland are also easily seen because they are not stained and will be visible in the surgical field
Although MB staining is not designed to be used as a sole technique it can be combined with other techniques such as identification of the anatomic landmarks MB staining is simple inexpensive and not time consuming techniqueIt is an indirect facial nerve identification technique because there is no nerve handlingthus decreasing iatrogenic nerve impairmentAfter injection of the parotid gland with MB dye fine white nerve fibers can be observed Tumors in the parotid gland are also easily seen because they are not stained and will be visible in the surgical field
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None