Mastectomy Clinical Trials

Clinical trials related to Mastectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
North Carolina
University of North Carolina at Chapel Hill Hospital
RECRUITING
Chapel Hill
Contact Information
Primary
Adeyemi Ogunleye, MD
yemi@med.unc.edu
(919) 966-4446
Backup
Alethia Burton
alethia_burton@med.unc.edu
9198435547
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 224
Treatments
Experimental: Xperience™ Advanced Surgical Irrigation
Active_comparator: Dilute Povidone-Iodine
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov