Summary
Background
Alloderm and Dermacell are the two leading human acellular dermal matrices (ADM) in
immediate breast reconstruction (IBR). Despite differences in sterility, consistency,
thickness and cost, there are no comparative trials to date to compare patient-reported
outcome measures (PROM) between the two products. The purpose of this study was to
determine if there was a difference in patient-reported outcomes (as measured by the
BREAST-Q) between patients reconstructed with Alloderm and Dermacell.
Methods
A single center, open-label, randomized control trial of patients undergoing IBR with
an implant for breast cancer or breast cancer prophylaxis was performed. Patients
were randomized to either Alloderm or Dermacell. Baseline demographic data were compared,
and linear mixed models were used to identify associations with BREAST-Q over time.
Results
Between June 2016 and October 2018, 62 patients were randomized into two groups, 31(50%)
Alloderm and 31(50%) Dermacell. Of these, 23(74%) patients in the Alloderm group and
27(87%) patients of the Dermacell group filled out BREAST-Q questionnaires. Baseline
BREAST-Q scores with respect to satisfaction with breasts, psychosocial well-being,
sexual well-being, and physical well-being were similar between groups (p>0.05). At 3 months postoperatively, the Alloderm group had a statistically significant
improvement with respect to satisfaction with breasts (67 vs 53, p = 0.03), satisfaction with overall results (85 vs 61, p = 0.003), satisfaction with the surgeon (89 vs 67, p = 0.01), and satisfaction with information provided (74 vs 59, p = 0.02). At 12 months postoperatively, there were no statistically significant differences
in PROM between groups (p>0.05).
Conclusion
We report the first randomized controlled trial to date comparing patient-reported
outcomes of the two most commonly used ADMs in IBR in Canada. Although a short-term
analysis favors the use of Alloderm, there does not appear to be any difference in
outcomes between the two products in the longer term.
Keywords
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Article info
Publication history
Published online: August 14, 2020
Accepted:
August 1,
2020
Received:
February 5,
2020
Footnotes
Previous communication to a society or meeting: The Canadian Society of Plastic Surgery Annual Meeting 2020.
Sources of funding: Financial support for this study came from the REthinking Clinical Trials (REaCT) program Ottawa.
Category: Randomized controlled trial.
Identification
Copyright
© 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
