Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512356
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2007-08-06
Brief Title:
Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
Status:
COMPLETED
Status Verified Date:
2017-08
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:
The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product AAP in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy laparotomy as a second procedure in the normal treatment of the subjects disease In both study groups surgical measures to prevent adhesions were taken eg using minimum traumatizing surgical technique using powder-free gloves In the investigational product group AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group The surgeon assessed preexisting adhesions during the first surgery Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization The safety of the study drug was also monitored
Detailed Description:
None
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