Advertisement

A comparison of patient-reported outcomes between Alloderm and Dermacell in immediate alloplastic breast reconstruction: A randomized control trial

Published:August 14, 2020DOI:https://doi.org/10.1016/j.bjps.2020.08.018

      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

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Plastic, Reconstructive & Aesthetic Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Albornoz C.R.
        • Bach P.B.
        • Mehrara B.J.
        • et al.
        A paradigm shift in U.S. breast reconstruction: increasing implant rates.
        Plast Reconstr Surg. 2013; 131: 15-23
        • Zienowicz R.J.
        • Karacaoglu E.
        Implant-based breast reconstruction with allograft.
        Plast Reconstr Surg. 2007; 120: 373-381
        • Becker S.
        • Saint-Cyr M.
        • Wong C.
        • et al.
        AlloDerm versus DermaMatrix in immediate expander-based breast reconstruction: a preliminary comparison of complication profiles and material compliance.
        Plast Reconstr Surg. 2009; 123 (discussion 107–108): 1-6
        • Stump A.
        • Holton III, L.H.
        • Connor J.
        • Harper J.R.
        • Slezak S.
        • Silverman R.P
        The use of acellular dermal matrix to prevent capsular formation around implants in a primate model.
        in: Paper presented at 25th Annual Meeting of the Northeastern Society of Plastic Surgeons, Philadelphia, Pa2008 (October 2–5)
        • Vardanian A.J.
        • Clayton J.L.
        • Roostaeian J.
        • et al.
        Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix.
        Plast Reconstr Surg. 2011; 128: 403e-410e
        • Sbitany H.
        • Sandeen S.N.
        • Amalfi A.N.
        • Davenport M.S.
        • Langstein H.N
        Acellular dermis–assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes.
        Plast Reconstr Surg. 2009; 124: 1735-1740
        • Bindingnavele V.
        • Gaon M.
        • Ota K.S.
        • Kulber D.A.
        • Lee D.J
        Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction.
        J Plast Reconstr Aesthetic Surg. 2007; 60: 1214-1218
        • Macadam S.A.
        • Lennox P.A.
        Acellular dermal matrices: use in reconstructive and aesthetic breast surgery.
        Can J Plast Surg. 2012; 20: 75-89
        • Chao A.H.
        a review of the use of acellular dermal matrices in postmastectomy immediate breast reconstruction.
        Plast Surg Nurs. 2015; 35 (quiz 135-6): 131-134
        • Nahabedian M.Y.
        Acellular dermal matrices in primary breast reconstruction: principles, concepts, and indications.
        Plast Reconstr Surg. 2012; 130: 44s-53s
        • Cheng A.
        • Saint-Cyr M.
        Comparison of different ADM materials in breast surgery.
        Clin Plast Surg. 2012; 39: 167-175
        • Zenn M.R.
        • Salzberg C.A.
        A direct comparison of alloderm-ready to use (RTU) and DermACELL in immediate breast implant reconstruction.
        Eplasty. 2016; 16 (eCollection 2016): e23
        • Becker S.
        • Saint-Cyr M.
        • Wong C.
        • et al.
        AlloDerm versus DermaMatrix in immediate expander-based breast reconstruction: a preliminary comparison of complication profiles and material compliance.
        Plast Reconstr Surg. 2009; 123 (discussion 107–108): 1-6
        • Pittman T.A.
        • et al.
        Comparison of different acellular dermal matrices in breast reconstruction: the 50/50 study.
        Plast Reconstr Surg. 2017; 139: 521-528
        • Arnaout A.
        • Zhang J.
        • Frank S.
        • et al.
        A randomized controlled trial comparing surgical outcomes of Alloderm and Dermacell in immediate implant based breast reconstruction.
        J Plast Reconstr Surg. 2020; (In Review)
      1. ClinicalTrials.gov. The use of alloderm versus dermacell in immediate implant based breast reconstruction (REaCT-ADM) NCT03064893. 2017[cited 2018 August 2018]; Available from: https://clinicaltrials.gov/ct2/show/NCT03064893.

        • Pusic A.L.
        • Klassen A.F.
        • Scott A.M.
        • Klok J.A.
        • Cordeiro P.G.
        • Cano S.J
        Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q.
        Plast Reconstr Surg. 2009; 124: 345-353
        • Politi M.C.
        • Wolin K.Y.
        • Légaré F
        Implementing clinical practice guidelines about health promotion and disease prevention through shared decision making.
        J Gen Intern Med. 2013; 28: 838-844
        • Kocak E.
        • et al.
        Biologic matrices in oncologic breast reconstruction after mastectomy.
        Expert Rev Med Devices. 2014; 11: 65-75
        • Bullocks J.M.
        DermACELL: a novel and biocompatible acellular dermal matrix in tissue expander and implant-based breast reconstruction.
        Eur J Plast Surg. 2014; 37: 529-538
        • Capito A.E.
        • et al.
        Evaluation of host tissue integration, revascularization, and cellular infiltration within various dermal substrates.
        Ann Plast Surg. 2012; 68: 495-500
        • Agrawal H.
        • et al.
        Macrophage phenotypes correspond with remodeling outcomes of various acellular dermal matrices.
        Open J Regener Med. 2012; 1: 51
        • Vashi C.
        Clinical outcomes for breast cancer patients undergoing mastectomy and reconstruction with use of DermACELL, a sterile, room temperature acellular dermal matrix.
        Plast Surg Int. 2014; 2014704323
        • Dikmans R.E.
        • Negenborn V.L.
        • Bouman M.B.
        • et al.
        Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial.
        Lancet Oncol. 2017; 18: 251-258
        • Lohmander F.
        • Lagergren J.
        • Roy P.G.
        • et al.
        Implant based breast reconstruction with acellular dermal matrix: safety data from an open-label, multicenter, randomized, controlled trial in the setting of breast cancer treatment.
        Ann. Surg. 2019; 269: 836-841
        • Dikmans R.E.G.
        • Negenborn V.L.
        • Bouman M.-.B.
        • et al.
        Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an openlabel, phase 4, multicentre, randomised, controlled trial.
        Lancet Oncol. 2017; 18: 251-258
        • Potter S.
        • Browning D.
        • Savovic J.
        • Holcombe C.
        • Blazeby J.M
        Systematic review and critical appraisal of the impact of acellular dermal matrix use on the outcomes of implant-based breast reconstruction.
        Br J Surg. 2015; 102: 1010-1025
        • Yoon C.
        • et al.
        Implant-based breast reconstruction using acellular dermal matrix and the risk of postoperative complications.
        Plast. Reconstr. Surg. 2010;
        • Negenborn V.L.
        • Young-Afat D.A.
        • Dikmans R.E.G.
        • et al.
        Quality of life and patient satisfaction after one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage breast reconstruction (BRIOS): primary outcome of a randomised, controlled trial.
        Lancet Oncol. 2018; 19: 1205-1214
        • Negenborn V.L.
        • Smit J.M.
        • Dikmans R.E.G.
        • et al.
        Short-term cost-effectiveness of one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage expander-implant reconstruction from a multicentre randomized clinical trial.
        Br J Surg. 2019; 106: 586-595