Patient Activated Controlled Tissue Expander System for Breast Reconstruction: A Prospective, Multi-Center, Randomized, Controlled, Open Label Clinical Study- Preliminary Results
Kamakshi Zeidler, MD1, R. Laurence Berkowitz, MD2, Debra Johnson, MD3, John Castle, MD4, Dan Morris, MD5, Yoon Chun, MD6, Amy Colwell, MD7, Ankit Desai, MD8, Kaveh Alizadeh, MD9, Scott Hollenbeck, MD10, James Appel, MD11, Khashayar Mohebali, MD12, Aldona Spiegel, MD13, Brian Thornton, MD14, Susan Downey, MD15, Greg Evans, MD16, Jeffrey Ascherman, MD17.
1Kamakshi R. Zeidler, MD, Los Altos, CA, USA, 2R. Laurence Berkowitz, MD, Campbell, CA, USA, 3Debra Johnson, MD, Sacramento, CA, USA, 4University of Massachusetts, Morshecter, MA, USA, 5Beth Israel Medical Center, Brookline, MA, USA, 6Faulkner Hospital, Boston, MA, USA, 7Massachusetts General, Boston, CA, USA, 8Ankit Desai, MD, Jacksonville, FL, USA, 9Long Island Plastic Surgery Group, Garden City, NY, USA, 10Duke University, Durham, NC, USA, 11Presbyterian Medical Center, Charlotte, NC, USA, 12Khashayar Mohebali, MD, Corte Madera, CA, USA, 13The Methodist Hospital, Houston, TX, USA, 14Brian Thornton, MD, Louisville, KY, USA, 15Susan Downey, MD, Los Angeles, CA, USA, 16University of California, Irvine, Orange, CA, USA, 17Columbia University, New York, NY, USA.
Background: Implant-based reconstruction is currently the most common method of breast reconstruction in women undergoing mastectomy for breast cancer treatment or prophylaxis. A two-stage approach to implant-based reconstruction using tissue expanders allows greater control over the skin envelope and results in improved symmetry. Current expanders are filled by bolus injections of saline over the course of months. This method effectively stretches the tissue but the process is time consuming and inconvenient for surgeons and patients. An innovative needleless breast tissue expander has been developed which is filled via an internal reservoir of CO2 using a remote control operated by the physician or patient.
Objective: Our purpose was to evaluate clinical effectiveness of the CO2-based tissue expander compared to saline expanders
Methods: Prospective, multicenter, randomized, controlled clinical study with target enrollment of 138 subjects at 17 investigational sites(USA). Participants electing two stage breast reconstruction, 18-70 years old, are randomized using a 2:1 permuted block design to the investigational or the saline expander arm. Tissue expansion in the investigational arm is accomplished using the remote control to deliver 10cc fills three times per day. Saline expansion in the control group was done per standard-of-care. Both groups were followed until explant of the tissue expander(s).
Results: Current study enrollment is 115(77 investigational(I)/38 control(C)) subjects. First-stage surgery has been completed in 107(69(I)/38(C)) subjects with 178(116(I)/61(C)) expanders implanted (bilateral rate 66%). Timing of reconstruction, surgical technique, use of acellular dermal matrix or latissimus flap coverage were selected by the investigators. To date, 87(61(I)/26(C)) subjects with 147(104(I)/43(C)) expanders have completed the study. Successful second-stage surgery, with exchange to a permanent implant, are completed in 78(53(I)/25(C)) subjects. Reasons for failed second-stage procedures were infection, delayed wound healing and incomplete expansion. Expansion was completed in the investigational arm in a mean of 18.7 days, median of 15±9.53(range 8-56) and in the control arm in a mean of 56.8 days, median of 53±33.9(range 5-137), a statistically significant difference (p<0.0001 (CI 95%)). Reconstruction was completed in the investigational arm in a mean time of 103.5 days, median of 98±45.55(range 42-237) and in the control arm in a mean of 157.1 days, median of 140±77.87(range 69-433), a statistically significant difference (p<0.0005 (CI 95%)).
Conclusions: The CO2 based tissue expander appears to be an effective method of expansion for breast reconstruction. Interim results indicate that tissue expansion and completion of reconstruction can be accomplished in a statistically significantly shorter time using the needle free patient controlled expander with a comparable risk profile to saline expanders. This innovative technology represents a safe and efficacious alternative to saline expansion and we expect that the final results will confirm our preliminary findings. With 98% of the women in the early phase of the study reporting that the expander is easy to use, adoption of this new technology is anticipated to be universal and will transform the process of tissue expansion.
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