Abstract: XPAND Patient-Activated Controlled Tissue Expander System for Breast Reconstruction: A Multi-Center Randomized Controlled Clinical Trial (Plastic Surgery 2014)

Sunday, October 12, 2014: 2:05 PM

Jeffrey A Ascherman, MD , Department of Surgery, Division of Plastic Surgery, New York Presbyterian Hospital, Columbia University Campus, New York, NY

R Laurence Berkowitz, MD , Aesthetic Plastic and Reconstructive Surgery, Campbell, CA

Gregory Evans, MD , Plastic Surgery Institute, University of California, Irvine, Orange, CA

Donald J. Morris, MD, FACS , Longwood Plastic Surgery, P.C., Harvard Medical School, Brookline, MA

Kamakshi R Zeidler, MD , Aesthetic Plastic and Reconstructive Surgery, Campbell, CA

Kaveh Alizadeh, MD , Long Island Plastic Surgery Group, Garden City, NY

Amy Colwell, MD , Plastic Surgery, Massachusetts General Hospital, Boston, MA

Ankit R Desai, MD , Desai Center of Plastic Reconstructive Surgery, Jacksonville, FL

Scott Hollenbeck, MD , Plastic and Reconstructive Surgery, Duke University Medical Center, Durham, NC

Debra J Johnson, MD , The Plastic Surgery Center, Sacramento, CA

Yoon S. Chun, MD , Division of Plastic Surgery, Department of Surgery, Harvard Medical School, Brigham and Women's Hospital/Faulkner Hospital, Boston, MA

Aldona J. Spiegel, MD , Institute for Reconstructive Surgery, The Methodist Hospital, Houston, TX

Khashayar Mohebali, MD , Plastic Surgery Specialists, Corte Madera, CA

Brian P Thornton, MD, PhD , Kentucky Aesthetics & Plastic Surgery Institute, Louisville, KY

James Appel, MD , Presyterian Medical Center - Charlotte, Charlotte, NC

Susan E. Downey, MD , Plastic and Reconstructive Surgery, Los Angeles, CA

John Castle, MD , Plastic Surgery, University of Massachusetts Memorial Medical Center, Worcester, MA

Presentation PDF file

Purpose: Implant-based breast reconstruction is the most common method of breast reconstruction in the United States and frequently involves a two-stage approach with tissue expanders. A novel patient-activated controlled expander, the AeroForm tissue expander, has been developed which obviates the need for saline injections associated with traditional expansion. Our objective was evaluation of the safety and effectiveness of the patient-controlled tissue expander compared to traditional saline expanders in a prospective, multicenter, randomized, controlled clinical trial.

Methods: Subjects, ages 18-70 with BMIs ≤33, were enrolled and randomized using a 2:1 permuted block design to either the investigational patient-controlled tissue expander or the saline expander control group and underwent immediate or delayed breast reconstruction. Patient-controlled expansion was performed using a 10-cc dose volume up to 30-cc/day. Saline expansion was performed according to current standard of care using percutaneous saline injections. Primary effectiveness was measured based on successful exchange to permanent implants. Failures to exchange due to device related events were considered study failures. Secondary outcome measures included time to desired expansion/exchange, pain scores and ease of use.

Results: The trial, conducted at seventeen clinical sites in the US, has enrolled 115/138 planned subjects with 107 (69 AeroForm/38 saline) treated. Successful exchange has been achieved in 61 of 69 subjects in the investigational arm and 36 of 38 subjects in the control arm. The reasons for failure to exchange were cellulitis, delayed wound healing, erosion, under-expansion or over-expansion. Mean time to desired expansion is 18.2 ą 9.2 days (AeroForm) and 57.4 ą 33.6 days (saline). Mean time to exchange is 106.3 ą 42.9 days (AeroForm) and 151.7 ą 62.6 (saline).

Conclusions: The investigational expander provides, relative to saline expanders, a needle free, time conserving and more convenient method of tissue expansion for breast reconstruction and is associated with high patient and physician satisfaction.

24813 XPAND Patient-Activated Controlled Tissue Expander System for Breast Reconstruction: A Multi-Center Randomized Controlled Clinical Trial