Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543823
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
ST250 as a Therapeutic Option for Head Neck Reconstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Use of Suprathel250 as a Novel Therapeutical Option for Mucosal Healing in Head and Neck Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
To assess the use of SupraThel 250 for mucosal reconstruction in the Head Neck region The membrane will be applied after tonsillectomy procedures and compared to bare wounds healing
Detailed Description:
After tonsillectomy procedures the wound is usually left bare to heal This causes severe pain postoperatively and postoperative hemorrhage SupraTHEL 250 is a synthetic biodegradable PLA membrane which is proven as a skin membrane in burn wounds with excellent result We therefore hypothesize that the use opf SupraTHEL 250 after tonsillectomy procedures will allow for faster less painful healing of the wound bed which allows for a better quality of life for the patients
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