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?

Intraoperative PVP-I (Povidone Iodine) antiseptic wash and complication rates in breast prosthesis surgery, analysis of observational Australian Breast Device Registry (ABDR) data

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12623000114640

Enrollment

30245

Registered

2023-02-03

Start date

2021-09-24

Completion date

2021-09-24

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Evidence supports the use of intra-operative antiseptic rinse in breast implant surgery to minimize the risk of capsular contracture or other complications. However, there is limited consensus or standardization of antiseptic rinse in practice. Having already determined contemporary trends in antiseptic rinse use in primary breast device surgery in Australia, we will use observational Australian Breast Device Registry (ABDR) data to analyse antiseptic rinse effects on clinical outcomes.

Interventions

The intervention is the use of intraoperative betadine (Povidone-Iodine) pocket rinse. All surgeons and hospital sites registered with the ABDR continue to report any implant-related surgeries to the ABDR on an ongoing basis. Follow-up/outcomes data are made up of explantation (removal of implant) surgeries made necessary by the respective post-operative complications. All follow-up surgeries reported to the ABDR will be obtained up to 31 Dec 2022 from the ABDR, allowing for a 'rolling' minimu

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results