This phase II trial compares the effect of surgical irrigation solution, Xperience, trademark, to dilute povidone-iodine irrigation solution on the prevention of surgical site infections in patients undergoing reconstruction after a mastectomy. Xperience is a solution containing citric acid, sodium citrate, and sodium lauryl sulfate. Xperience may breakdown biofilms and reduce bacteria. Povidone-iodine, an antimicrobial solution, may help prevent surgical site infections. A concern with current irrigation solutions, such as povidone-iodine, is that they must be rinsed after a certain dwelling time due to concerns of adverse effects to the surrounding tissues that can impair wound healing. Rinsing the solution may have a negative impact on the ability of the solution to prevent infection. Xperience does not require rinsing and extends the exposure time. Irrigating with Xperience may be more effective compared to dilute povidone-iodine in preventing surgical site infections in patients undergoing reconstruction after a mastectomy.
Additional locations may be listed on ClinicalTrials.gov for NCT06649890.
Locations matching your search criteria
United States
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer CenterStatus: Active
Contact: Yemi Ogunleye
Phone: 919-843-1286
PRIMARY OBJECTIVES:
I. Obtain preliminary data to support the intra-operative use and clinical efficacy of Xperience™ irrigation solution over dilute povidone-iodine irrigation for tissue expander placement in post-mastectomy breast reconstruction.
Ia. Compare the incidence of surgical site infection after tissue expander placement with use of intra-operative Xperience™ irrigation versus dilute povidone-iodine irrigation;
Ib. Compare the incidence of premature tissue expander removal after tissue expander placement with use of intra-operative Xperience™ irrigation versus dilute povidone-iodine irrigation;
Ic. Compare the incidence of any post-surgical complications after tissue expander placement with use of intra-operative Xperience™ irrigation versus dilute povidone-iodine irrigation;
Id. Investigate risk factors for tissue expander infection, premature tissue expander removal, and other post-surgical complications after tissue expander placement with intra-operative Xperience™ irrigation versus dilute povidone-iodine irrigation. (Tissue expander focused [immediate or delayed TE placement])
II. Obtain preliminary data to support the intra-operative use and clinical efficacy of Xperience™ irrigation solution over dilute povidone-iodine irrigation for saline or silicone implants (direct-to-implant placement or tissue expander to implant exchange) in post-mastectomy breast reconstruction.
IIa. Compare the incidence of surgical site infection after implant placement with use of intra-operative Xperience™ irrigation versus dilute povidone-iodine irrigation;
IIb. Compare the incidence of implant explantation with use of intra-operative Xperience™ irrigation versus dilute povidone-iodine irrigation;
IIc. Compare the incidence of any post-surgical complications after implant placement with use of intra-operative Xperience™ irrigation versus dilute povidone-iodine irrigation;
IId. Investigate risk factors for implant infection, explantation, and other post-surgical complications after implant placement with intra-operative Xperience™ irrigation versus dilute povidone-iodine irrigation. (Implant Focused [direct-to-implant placement or tissue expander to implant exchange])
OUTLINE: Breasts are randomized to 1 of 2 arms.
ARM I (RIGHT BREAST): Patients undergo placement of tissue expander or implant or removal tissue expander and placement of implant on day 0. Patients receive Xperience irrigation solution to the right breast mastectomy pocket over 1 minute and povidone-iodine irrigation solution to the left breast mastectomy pocket over 1 minute during surgery.
ARM II (LEFT BREAST): Patients undergo placement of tissue expander or implant or removal tissue expander and placement of implant on day 0. Patients receive Xperience irrigation solution to the left breast mastectomy pocket over 1 minute and povidone-iodine irrigation solution to the right breast mastectomy pocket over 1 minute during surgery.
After completion of study treatment, patients are followed up at days 7, 14, 21 and 28 and then bi-monthly (days 42, 56, 70, and 84-90) for up to day 90.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorYemi Ogunleye
