Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649890
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-14
Brief Title:
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction Evaluating Xperience
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Control Trial Evaluating the Efficacy of Xperience Surgical Irrigation Solution Versus Dilute Povidone-Iodine in Preventing Surgical Site Infections and Improving Postoperative Outcomes in Implant-Based Breast Reconstruction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Goal of the Clinical Trial
The purpose of this clinical trial is to learn whether Xperience surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections SSIs following implant-based breast reconstruction in female patients aged 18 and older It will also assess the safety and overall surgical outcomes when using Xperience compared to povidone-iodine
Main Questions the Study Aims to Answer
Does the use of Xperience decrease the incidence of surgical site infections compared to povidone-iodine
What are the differences in the rates of premature implant removal due to infection between patients treated with Xperience and those treated with povidone-iodine
Are there fewer post-surgical complications with Xperience compared to povidone-iodine
Study Design
Participants in this study will be randomly assigned to receive either Xperience or a dilute povidone-iodine solution during their bilateral implant-based breast reconstruction Only the research team will know which irrgiation is given- the participant will not know
Participant Will
Undergo the surgical procedure using one of the two irrigation solutions
Receive regular post-operative check-ups to monitor for signs of infection and other complications
Have data collected on any post-surgical complications the necessity for early implant removal and overall surgical outcomes
The purpose of this clinical trial is to learn whether Xperience surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections SSIs following implant-based breast reconstruction in female patients aged 18 and older It will also assess the safety and overall surgical outcomes when using Xperience compared to povidone-iodine
Main Questions the Study Aims to Answer
Does the use of Xperience decrease the incidence of surgical site infections compared to povidone-iodine
What are the differences in the rates of premature implant removal due to infection between patients treated with Xperience and those treated with povidone-iodine
Are there fewer post-surgical complications with Xperience compared to povidone-iodine
Study Design
Participants in this study will be randomly assigned to receive either Xperience or a dilute povidone-iodine solution during their bilateral implant-based breast reconstruction Only the research team will know which irrgiation is given- the participant will not know
Participant Will
Undergo the surgical procedure using one of the two irrigation solutions
Receive regular post-operative check-ups to monitor for signs of infection and other complications
Have data collected on any post-surgical complications the necessity for early implant removal and overall surgical outcomes
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