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Purpose: Implant-based breast reconstruction is the most common method of breast reconstruction and generally involves a two-stage approach that includes initial placement of a tissue expander, followed by exchange to an implant. The traditional expansion process requires serial saline injections that can be laborious, prolonged, and disruptive for patients. A novel patient-activated controlled expander has been developed and obviates the need for saline injections. The system allows patients to control the expansion process by a wireless handheld dosage controller, which activates release of a predetermined volume of carbon dioxide from within the tissue expander. Our purpose was to evaluate clinical outcomes and effectiveness of the patient-controlled tissue expander compared to traditional saline expanders.
Methods: A multicenter, randomized, controlled clinical trial is in progress whereby women participants, ages 18-65 years, are randomized using a 2:1 permuted block design to either the investigational patient-controlled tissue expander or the saline expander control group for either immediate or delayed breast reconstruction. Patient-controlled tissue expansion is performed according to protocol using a 10-cc dose volume limitation not to exceed 30cc/day. Saline expansion is performed according to current standard of care using percutaneous saline injections. Both groups are followed in the same manner until explantation and exchange to permanent implant, and their performance is compared. Outcome measures include post-operative complications, time-to-desired-expansion and to exchange procedure, pain ratings during expansion, and patient and physician satisfaction.
Experience and Results: The trial is enrolling up to 138 total subjects at 10 U.S. clinical sites. Ninety-two breast expansions will be performed with patient-controlled tissue expanders; 46 breast expansions will be performed using saline expanders. Sixteen patient-controlled tissue expanders and 7 saline expanders have been implanted. One patient with a patient-controlled device has completed the expansion and reconstruction process. There have been no reported device-related adverse events. Enrollment should be complete by May and results should be final and evaluable by September 2012.
Conclusions: Tissue expander/implant-based reconstruction remains an important breast reconstruction treatment option. The patient-controlled tissue expander system introduces a novel tissue expansion process, eliminating the need for percutaneous saline injections traditionally required for saline expanders.
Top: Dosing curve for patient-controlled expansion (right breast, nipple-sparing mastectomy) over 7 days from start of dosing until full expansion. Bottom: Same patient after full expansion and before exchange to permanent implant.