Clinical trial NCT06649890: A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Site Infection
Surgical Complication
Implant Infection
Implant Complication
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Surgical Site Infections
timeFrame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Secondary outcomes:
measure: Rate of Implant Explantation
timeFrame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
measure: Rate of Non-Infectious Post-Surgical Complications
timeFrame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Adeyemi Ogunleye, MD
role: PRINCIPAL_INVESTIGATOR
References: