XPAND Study

Abstract

INTRODUCTION: Implant-based breast reconstruction generally involves a two-stage approach with initial placement of a tissue expander, followed by exchange to a permanent implant. A novel patient-controlled expander has been developed and obviates the need for saline injections to fill the expander. Our purpose was to evaluate clinical outcomes and effectiveness of the patient-controlled tissue expander compared to traditional saline expanders. METHODS: Multicenter, randomized, controlled clinical trial. Women participants, ages 18-70 years, were randomized using a 2:1 permuted block design to either the investigational tissue expander or the saline expander control group. Patient-controlled tissue expansion was performed with a remote control to deliver a 10-cc dose volume not exceeding 30 cc/day. Saline expansion involved current standard-of-care percutaneous saline injections. Both groups were followed until exchange to permanent implant, and implant performance was compared. RESULTS: Ninety-two patient-controlled expanders and 46 saline expanders will be implanted in up to 138 subjects at 11 U.S. clinical sites. To date, 55 patient-controlled expanders and 21 saline expanders have been implanted; 14 subjects with 23 patient-controlled expanders (Figures 1 and 2) and 4 subjects with 6 saline expanders have completed reconstruction.Figure 1: Dosing curve for patient-controlled expansion (right breast, nipple-sparing mastectomy) over 7 days from start of patient dosing until full expansion.Figure 2: Same patient (right breast, nipple-sparing mastectomy) after full expansion and before exchange to permanent implant.CONCLUSION: Tissue expander/implant-based reconstruction remains an important breast reconstruction treatment option. The patient-controlled tissue expander system introduces a needle-free tissue expansion process, eliminating the need for percutaneous injections traditionally required for saline expanders.