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NCT06649890 · ClinicalTrials.gov registry record · NA
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
A NA study of Surgical Site Infection and Surgical Complication, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 224
- Enrollment target
- 1
- Study location
NCT06649890: Recruiting NA study of Surgical Site Infection and Surgical Complication, sponsored by University of North Carolina, Chapel Hill.
NCT06649890 is a NA study of Surgical Site Infection and Surgical Complication that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 224 participants, below the 559-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06649890, a NA study of Surgical Site Infection and Surgical Complication, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 224 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of patients diagnosed with surgical site infections as per the diagnostic criteria outlined by the Centers for Disease Control National Healthcare Safety Network's 2024 Breast Surgery (BRST) Surgical Site Infection Criteria.
Conditions Studied
Interventions
- DEVICE Xperience™ Advanced Surgical Irrigation
- DEVICE Dilute Povidone-Iodine
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill Hospital - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2025-06-30 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
What NCT06649890 shows while recruiting
NCT06649890 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 559-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (60% lower).
The record links to 4 conditions, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which Xperience™ Advanced Surgical Irrigation is the first listed.
NCT06649890 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06649890 about?
NCT06649890 is a clinical study titled "A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™". 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, ...
What is the current status of trial NCT06649890?
This trial is currently recruiting. It is a NA study. The enrollment target is 224 participants. The study started on 2025-06-30. Estimated completion is 2028-06-30.
What conditions does trial NCT06649890 study?
This clinical trial studies the following conditions: Surgical Site Infection, Surgical Complication, Implant Complication, Implant Infection.
What interventions are being tested in trial NCT06649890?
The interventions under investigation include: Xperience™ Advanced Surgical Irrigation (DEVICE), Dilute Povidone-Iodine (DEVICE).
Who is sponsoring clinical trial NCT06649890?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06649890 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06649890's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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