Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227084
Status:
COMPLETED
Last Update Posted:
2007-08-27
First Post:
2005-09-23
Brief Title:
Effect of Arista Powder on Bleeding in Reductive Mammary Surgery
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
Effect of Arista AH-Haemostatic Powder in Plastic Surgery A Prospective Consecutive Randomized Study in 30 Women Undergoing Reduction of Both Mamma
Status:
COMPLETED
Status Verified Date:
2007-08
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:
To evaluate whether Arista AH which contains microporous polysaccharides used as a powder applied to the wound area during mammary surgery reduces the amount of bleeding and the duration of surgery Both mammae are operated on in the same procedure and one side without Arista serves as control side
Detailed Description:
During the operationbefore the first incision a randomization envelope is opened Always starts on the same side with or without Arista according to the envelope After surgery vacuum drains are placed and the amount of drained material and hgb content is measured 24 hours later by nursing staff blinded to what side had AristaPatients scores postoperative pain with VAS score bilaterally
Three months postoperatively the patients are checked by a physician blinded for what side had Arista
Three months postoperatively the patients are checked by a physician blinded for what side had Arista
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