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New treatment option for Surgical Site Infection
Official title A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
ClinicalTrials.gov ID: NCT06649890
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Older than 18 years old
- Willing to comply with all study-related procedures
- Available for the duration of the study
- Participants undergoing double mastectomy surgery followed by one of the following: (1) Immediate reconstruction with tissue expander placement, (2)...
You likely can't join if
- Participants unable to participate in follow-up visits
- Participants undergoing unilateral mastectomy
- Tissue expanders placed by a surgeon outside of the UNC Chapel Hill Hospital System
- Undergoing autologous reconstruction
- Participant is unable to provide signed and dated informed consent
- Unwilling or unable to comply with all study-related procedures.
See the full eligibility criteria
- Older than 18 years old
- Willing to comply with all study-related procedures
- Available for the duration of the study
- Participants undergoing double mastectomy surgery followed by one of the following: (1) Immediate reconstruction with tissue expander placement, (2) Delayed reconstruction with tissue expander or implant placement, (3)...
- Participants unable to participate in follow-up visits
- Participants undergoing unilateral mastectomy
- Tissue expanders placed by a surgeon outside of the UNC Chapel Hill Hospital System
- Undergoing autologous reconstruction
- Participant is unable to provide signed and dated informed consent
- Unwilling or unable to comply with all study-related procedures.
- Known history of sensitivity or allergic reaction to any of the components of the Xperience™ irrigation solution or dilute povidone-iodine irrigation
- Participant with any conditions that would be a contraindication to receiving surgery such as contraindications to general anesthesia
- Pregnant, planning to become pregnant or breast feeding participants
- Individuals providing informed consent with any mental impairment or condition that would make them unable to properly consent without use of legally authorized representative (LAR) or additional participant protections.
- Incarcerated participants
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.