ABSTRACT
Background The use of acellular dermal matrix (ADM) for post-mastectomy reconstruction is considered by many surgeons to be an accepted component of surgical technique. Early clinical experience is described for SimpliDerm® - a novel human ADM (Aziyo Biologics, Silver Spring, USA), and AlloDerm® Ready-To-Use (RTU) - an established ADM (Allergan Medical, Irvine, USA). Methods Records were retrospectively reviewed from four sites between 2016 and 2021 of patients who underwent immediate, two-stage reconstruction with either SimpliDerm (n=38) or AlloDerm RTU (n=69) after mastectomy and were followed out to exchange to permanent implant(s), tissue expander(s) explant, or death. Results Immediate breast reconstruction with tissue expanders and ADM was performed on 107 patients (181 breasts). Overall mean patient age was 51.4 ± 12.4 years, and mean BMI was 28.0 ± 5.8 kg/m2. Significantly more patients in the SimpliDerm group were of Hispanic or Latino ethnicity (34.2% vs. 7.2%; P<.001). Reconstructions were predominantly prepectoral (82.3%). A total of 35 adverse events (AEs) occurred in 27 (25.2%) patients, with no difference in AE type, classification, or rates between ADM groups. No AEs were considered related to either ADM. The observed AE profiles and rates are similar to those published for other ADMs in immediate breast reconstruction. Conclusions There continues to be a need for additional clinically equivalent ADMs to provide physicians with more availability and options for their practice. This retrospective, multisite study describes comparable clinical outcomes with SimpliDerm and AlloDerm RTU through a median of 133.5 days (~four months) following immediate two-stage breast reconstruction.
ABSTRACT
BACKGROUND: Acellular dermal matrix (ADM) is widely used in breast reconstruction, and outcomes of these procedures may be improved through optimized product design. SimpliDerm is a new human ADM designed to closely preserve the architecture of native dermis, with the goal of improving surgical outcomes. This study reports the initial (30-day) clinical experience with SimpliDerm compared with AlloDerm Ready-To-Use (RTU) in ADM-assisted breast reconstruction. METHODS: Clinical characteristics and outcomes of 59 consecutive patients who underwent immediate 2-stage reconstruction with SimpliDerm (n = 28) or AlloDerm RTU (n = 31) following mastectomy are reported. RESULTS: Fifty-nine women (108 breasts) underwent posmastectomy breast reconstruction with SimpliDerm or AlloDerm RTU. Mean patient age was 51.1 years, and mean body mass index was 28.2 kg/m2. Reconstructions were predominantly prepectoral (95.4%), used tissue expanders (100%), and followed a skin-sparing (64%) approach to mastectomy. Mean time to final drain removal did not differ between groups (17.0 days, SimpliDerm versus 17.7 days, AlloDerm RTU). Adverse events occurred in 13 (22%) patients; none considered serious-all were mild or moderate in intensity. Adverse event rates did not differ between groups. The observed adverse event profiles and rates are similar to those published for other ADMs in immediate breast reconstruction. CONCLUSIONS: There remains a clinical need for ADMs with more optimal characteristics. This case series describes comparable outcomes with SimpliDerm and AlloDerm RTU over 30 days after immediate 2-stage breast reconstruction.
ABSTRACT
A surgical technique using local tissue skate flaps combined with cylinders made from a naturally derived biomaterial has been used effectively for nipple reconstruction. A retrospective review of patients who underwent nipple reconstruction using this technique was performed. Comorbidities and type of breast reconstruction were collected. Outcome evaluation included complications, surgical revisions, and nipple projection. There were 115 skate flap reconstructions performed in 83 patients between July 2009 and January 2013. Patients ranged from 32 to 73 years old. Average body mass index was 28.0. The most common comorbidities were hypertension (39.8%) and smoking (16.9%). After breast reconstruction, 68.7% of the patients underwent chemotherapy and 20.5% underwent radiation. Seventy-one patients had immediate breast reconstruction with expanders and 12 had delayed reconstruction. The only reported complications were extrusions (3.5%). Six nipples (5.2%) in 5 patients required surgical revision due to loss of projection; two patients had minor loss of projection but did not require surgical revision. Nipple projection at time of surgery ranged from 6 to 7 mm and average projection at 6 months was 3-5 mm. A surgical technique for nipple reconstruction using a skate flap with a graft material is described. Complications are infrequent and short-term projection measurements are encouraging.
