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BACKGROUND: Tissue expander breast reconstruction is advantageous for its shorter operating times, decreased scarring, and potentially decreased morbidity compared to autologous reconstruction. Despite these advantages, some women report greater dissatisfaction than with autologous options. Reasons for this include a potentially long period of postoperative care, prolonged pain with expansion, and multiple office visits for saline injections. A newly developed device allows for patient-controlled tissue expansion without the need for percutaneous injections and multiple office visits. The patient uses a remote control device at home to release small doses of carbon dioxide from a cartridge built into the expander, leading to steady, daily expansion. This method has the potential to shorten the time to final expansion, reduce pain, and improve patient satisfaction. The purpose of this study is to evaluate the clinical outcomes and effectiveness of this device compared to traditional saline expanders at our institution.
METHODS: We are reporting the results of this device in a randomized, controlled clinical trial at a single academic medical center. Women between 18 and 65 years old in need of either immediate or delayed breast reconstruction are randomized in a 2:1 ratio to either the patient-controlled expander or the traditional saline expander control group. The patient controlled expander system allows one 10-cc dose of carbon dioxide to be self-administered every 3 hours up to 3 doses (or 30 cc) per day. Saline expansion involves the current standard of saline injections in the office every 2 to 3 weeks. Experimental and control groups are followed in the same manner until exchange for a permanent implant. Outcomes are compared, and include complications, pain during expansion, satisfaction, and time to final expansion and implant exchange.
RESULTS: We have enrolled a total of 12 patients in the trial to date. Of those, 3 patients in the experimental group have finished expansion and undergone exchange for permanent implants. These 3 patients reached their final desired expander volume in an average of 18 days after they began at-home tissue expansion, with a range of 6 to 29 days. The average pain rating during expansion for these 3 patients was 1.6 on a 10 point numeric scale, with 0 representing no pain and 10 representing severe pain. Patient satisfaction with the experimental device has been excellent, and all patients have stated they would recommend the device to others. To date, there have been no device related complications. The remainder of our patients have not finished expansion, or are awaiting exchange for their permanent implant. (Updated results will be presented at the meeting, by which time most of these patients will have completed the study.)
CONCLUSIONS: Although traditional tissue expansion with saline-based expanders is a cornerstone of breast reconstruction, outcome studies looking at patient satisfaction have highlighted the need for improvements. The patient-controlled tissue expander has the potential to address some of the disadvantages of traditional tissue expansion by reducing pain, eliminating the need for multiple office visits, and shortening the time between expander placement and implant exchange.