A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™

University of North Carolina (UNC)

Status

Enrolling

Conditions

Implant Infection

Surgical Site Infection

Implant Complication

Surgical Complication

Treatments

Device: Xperience™ Advanced Surgical Irrigation

Device: Dilute Povidone-Iodine

Study type

Interventional

Funder types

Other

Identifiers

NCT06649890

24-0853

Details and patient eligibility

About

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.

Enrollment

224 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion 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) Immediate reconstruction with implant placement, (4) Second-stage reconstruction with tissue expander to implant exchange

Exclusion criteria

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