The use of tissue expanders for breast reconstruction – what you put in is not always what you get out! A Pilot study of Tissue Expander fill and final volumes

The use of tissue expanders for breast reconstruction – what you put in is not always what you get out! A Pilot study of Tissue Expander fill and final volumes in women undergoing breast reconstruction after mastectomy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000877785

Enrollment

Registered

2013-08-07

Start date

2012-02-14

Completion date

2012-07-25

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of this study is to evaluate tissue expander fill and final volumes in women undergoing breast reconstruction. Who is it for? This study included women who underwent tissue expander/implant based breast reconstruction following mastectomy. The surgeries were conducted over a 6 month period in 2012. Trial details All participants in this study underwent breast reconstruction surgery with tissue expander. The tissue expander fill volume inserted at the time of first implant was compared to the final volume on removal of the tissue expander at the time of second stage reconstructions (about 3-4 months later). A discrepancy between these values affects the size of the second stage implant and thus the cosmetic outcome.

Interventions

Assessing the difference in the fill volumes inserted into a tissue expander and the final volumes on removal of the tissue expander. A descrepency has been noted that will effect the size of the second stage implant that is inserted into the sub-pectoral pocket and thus the cosmetic outcome. Type of Tissue expanders studied: 133MV Allergan style tissue expanders The tissue expander is assessed at the time of second stage reconstruction which is usually anywhere between 3-4 months after the init

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

All patients undergoing Tissue expander/Implant based breast reconstruction after mastectomy - 6 month period in 2012

Exclusion criteria

Ruptured/leaking tissue expanders

Outcome results