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

Not Applicable

Not yet recruiting

• Conditions: Surgical Site Infection; Surgical Complication; Implant Infection; Implant Complication

• Registration Number: NCT06649890
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-14
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-17
• Last Update Submitted: 2024-10-17
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Study Start: 2024-12-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 224

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Surgical Site Infections	Within 90 days of implant/tissue expander placement, with the day of placement Day 0.	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Implant Explantation	Within 90 days of implant/tissue expander placement, with the day of placement Day 0.	Number of patients who required non-elective implant explantation.
Rate of Non-Infectious Post-Surgical Complications	Within 90 days of implant/tissue expander placement, with the day of placement Day 0.	Number of patients who experience the the following, but not limited to, post-surgical complications: * Delayed wound healing (superficial incisional dehiscence requiring serial dressing changes, office debridement and/or operative revision); * Hematoma; * Seroma; * Tissue expander leak/rupture; * Tissue expander/Implant exposure/extrusion

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill Hospital; 🇺🇸 Chapel Hill, North Carolina, United States