Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00524511
Status:
TERMINATED
Last Update Posted:
2013-03-05
First Post:
2007-08-31
Brief Title:
Comparison Study of Wound Closure at Time of Cesarean Delivery Dermabond Glue Versus Surgical Staples
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
A Comparative Study of Closure Techniques After Cesarean Section Staples vs Dermabond
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment much data was missing as patients were lost to follow up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Women who have a cesarean delivery have a surgical incision on their abdomen belly The usual way to close this opening is with metal surgical staples In many other types of surgery surgical incisions are closed with a super-glue called Dermabond The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery but this has not been studied Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond The researchers will survey the patients to see how they felt about the experience and the appearance of their scar The researchers will survey physicians performing the surgery to see how easy Dermabond was to use The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications such as bruising infection or separation of the wound in the two groups
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