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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Not yet 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

224 participants in 2 patient groups

Xperience™ Advanced Surgical Irrigation
Experimental group
Treatment:
Device: Xperience™ Advanced Surgical Irrigation
Dilute Povidone-Iodine
Active Comparator group
Treatment:
Device: Dilute Povidone-Iodine

Trial contacts and locations

1

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Central trial contact

Alethia Burton; Adeyemi Ogunleye, MD

Data sourced from clinicaltrials.gov

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