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

Not Applicable

Completed

• Conditions: Pilot study involving the volumes of tissue expanders used in breast cancer related reconstructive surgeries; Surgery - Surgical techniques; Cancer - Breast

• Registration Number: ACTRN12613000877785
• Lead Sponsor: Dr Ananda Kallyani S M Ponniah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

Ruptured/leaking tissue expanders

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in the volumes noted effect the size of the implant that is inserted into the sub-pectoral pocket. Surgeons should be aware of this descrepency and have a wide range of implant sizes available at the time of the second stage reconstructive surgery.<br>The fill volume is based on the total amount of normal saline inserted into the tissue expanders by the surgeon (intra-operatively at the 1st stage and at office based insertions<br>The final volume is measured in 2 ways; by volume displacement by placing the removed TE into a graduated beaker containing 500ml of fluid as well by weighing the TE itself.[This is a pilot study of 32 tissue expanders evaluated in a 6 month period. An extension is planned.<br>Volume is measured at the time of the second stage implant reconstruction]

Secondary Outcome Measures

Name	Time	Method
The fill volume is based on the total amount of normal saline inserted into the tissue expanders by the surgeon (intra-operatively at the 1st stage and at office based insertions<br>The final volume is measured in 2 ways; by volume displacement by placing the removed TE into a graduated beaker containing 500ml of fluid as well by weighing the TE itself.<br>To postulate the cause of this decrepency - we assessed the biochemistry of the fluid within the tissue expanders at the 2nd stage surgery to determine if there was ingress of plasma into the normal saline that was inserted and we did find small amounts of plasma constituents; this points towards a defect in the valves. Other investigators have also assessed the valve mechanisms, osmotic gradients across the membranes and colloid osmotic swelling.[6 months]