AlloDerm RTU Integration and Clinical Outcomes When Used for Reconstructive Breast Surgery

Abstract

Background:AlloDerm Ready To Use (RTU) is a sterile version of AlloDerm regenerative tissue matrix, developed in response to concerns regarding the potential risk of infectious complications with the latter aseptic matrix. Clinical data on AlloDerm RTU use is, however, limited, particularly with respect to histologic evidence of graft integration and clinical outcomes.Methods:Consecutive patients who underwent tissue-expander/implant reconstruction with the use of AlloDerm RTU from March 2011 to September 2012 were included in this analysis. Biopsies of AlloDerm RTU/capsule interface were obtained at the time of expander/implant exchange and evaluated for evidence of cellularization, vascularization, and inflammatory reaction. Data on postoperative complications were retrieved from patient records.Results:A total of 116 biopsy specimens from 68 patients were obtained. At biopsy, on visual inspection, nearly all grafts were fully integrated within the host tissue. Histologically, graft specimens demonstrated mild-to-moderate neovascularization and cellular repopulation with no inflammatory cells. All patients were followed for 5 years postoperatively. Short-term postoperative complications of skin necrosis, seroma, and infection occurred in 10.3%, 4.3%, and 2.6% of reconstructions, respectively. Capsular contracture (grade 3) was the only long-term complication (5.2%). Rates of short- and long-term complications are similar to those observed in our previous experience with AlloDerm reconstructive tissue matrix.Conclusions:AlloDerm RTU used in breast reconstructive surgery fully integrates and incorporates into host tissue. There were no unexpected safety concerns with its use at short-term or at long-term, at least up to 5 years of follow-up.

In Vitro Characterization of a Novel Human Acellular Dermal Matrix (BellaCell HD) for Breast Reconstruction

“…Histological observation showed early graft integration at 6 weeks post-implantation [26]. Clinical data on AlloDerm RTU used in breast reconstruction showed full incorporation and integration into the host tissue [27]. Based on the present study, BellaCell might also reduce complications that lead to reconstruction failure.…”

Acellular Dermal Matrix Reduces Myofibroblast Presence in the Breast Capsule

“…5,19 The integration of ADM into host tissue has been demonstrated histologically and, thus, has further supported its preventative effect on capsular contracture development. 3,13,16,20,21…”

A Randomized Controlled Trial Comparing Alloderm-RTU with DermACELL in Immediate Subpectoral Implant-Based Breast Reconstruction

“…It is recognized that having breast restoration immediately post-mastectomy (i.e., direct to implant breast reconstruction) significantly improves patient care [ 24 ], wellbeing [ 25 , 26 ], and also offers cost savings from sparing a second surgery [ 27 , 28 , 29 ]. ADM use has also been associated with improved aesthetic outcomes [ 30 , 31 ], and thus an ADM-assisted breast reconstruction has become the preferred approach at many centres globally [ 32 , 33 , 34 , 35 , 36 ]. For USD $25–$35 per square cm (most commonly used sizes are 6 cm × 16 cm), there is a need to perform high-quality clinical trials evaluating the performance, safety, and post-surgical outcomes of the various ADMs in this era of value-based care [ 27 , 28 , 29 ].…”

“…For example, proponents of DermACELL advocate for its increased sterility; but whether the difference in sterility translates into a clinical difference in infection rate is unclear (the standard procedure is to sterilize to 10 −6 for operative devices) [ 37 , 38 ]. Supporters of Alloderm-RTU advocate based on its long term data on safety and effectiveness, although most studies were performed with the original freeze-dried version (sterilized to 10 −6 ) and not the RTU product [ 3 , 9 , 10 , 35 , 36 ].…”