Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614829
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIXDERMABOND PRINEO Wound Closure CS-PREO
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
CS-PREO
Brief Summary:
The aim of the study is to compare outcomes between patients receiving standard C-section wound closure compared to a wound closure bundle that includes Stratafix sutures and Dermabond PRINEO
Detailed Description:
The purpose of this study is to evaluate patient experience and patient reported outcomes following cesarean delivery in women receiving either standard wound closure or a wound closure bundle which includes both Stratfix sutures and Dermabond Prineo
Patients in both study arms will complete established questionnaires capturing patient-reported experience measures PREMS and patient-reported outcome measures PROMS
Patients in both study arms will complete established questionnaires capturing patient-reported experience measures PREMS and patient-reported outcome measures PROMS
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