Does the use of intraoperative PVP-I (Povidone Iodine; Betadine) antiseptic wash in breast device surgery lower complication rates resulting in removal of the implants?

Not Applicable

Completed

• Conditions: Post-operative infection; Capsular Contracture; Breast implant surgery; Surgery - Surgical techniques; Surgery - Other surgery

• Registration Number: ACTRN12623000114640
• Lead Sponsor: Robert Knight

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-31
• Study Start: 2023-02-03
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30245

Inclusion Criteria

Primary (First) Breast device surgery between 1 Jan 2015 to 31 Dec 2020 as reported to the ABDR

Exclusion Criteria

Device revision surgeries
Tissue expander insertion
Tissue expander removal and implant insertion
Concurrent mastectomy
Axillary surgery including sentinel node biopsy
Concurrent flap cover

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deep infection requiring explantation as indicated by the operating surgeons in the ABDR data collection forms[Within first 30-60 days after primary breast implant surgery];Capsular contracture requiring explantation as indicated by the operating surgeons in the ABDR data collection forms[Within first 18-24 months after primary breast implant surgery]

Secondary Outcome Measures

Name	Time	Method
Capsular contracture requiring explantation as indicated by the operating surgeons in the ABDR data collection forms[Any time from surgery to 2 years after primary breast implant surgery];Implant deflation or rupture requiring explantation as indicated by the operating surgeons in the ABDR data collection forms[Within first 18-24 months after primary breast implant surgery]