title: Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial.
abstract: BACKGROUND
  Comparative studies on the use of meshes and acellular dermal matrices (ADM) in implant-based breast reconstruction (IBBR) have not yet been performed.
  
  
  METHODS
  This prospective, randomized, controlled, multicenter pilot study was performed at four Austrian breast cancer centers. Fifty patients with oncologic or prophylactic indication for mastectomy and IBBR were randomized to immediate IBBR with either an ADM (Protexa(®)) or a titanized mesh (TiLOOP(®) Bra). Complications, failed reconstruction, cosmetic outcome, patients' quality of life and the thickness of the overlying tissue were recorded immediately postoperatively and 3 and 6 months after surgery.
  
  
  RESULTS
  48 patients participated in the study (Protexa(®) group: 23; TiLOOP(®) Bra group: 25 patients). The overall complication rate was 31.25% with similar rates in both groups (Protexa(®) group: 9 versus TiLOOP(®) Bra group: 6; p = 0.188). There was a higher incidence of severe complications leading to failed reconstructions with implant loss in the Protexa(®) group than in the TiLOOP(®) Bra group (7 versus 2; p < 0.0001). An inverted T-incision technique led to significantly more complications and reconstructive failure with Protexa(®) (p = 0.037, p = 0.012, respectively). There were no significant differences in patients' satisfaction with cosmetic results (p = 0.632), but surgeons and external specialists graded significantly better outcomes with TiLOOP(®) Bra (p = 0.034, p = 0.032).
  
  
  CONCLUSIONS
  This pilot study showed use of TiLOOP(®) Bra or Protexa(®) in IBBR is feasible leading to good cosmetic outcomes and high patient satisfaction. To validate the higher failure rates in the Protexa(®) group, data from a larger trial are required. NCT02562170.
authors.affiliation: Medical University of Vienna, Breast Cancer Center, Department of Gynaecological Oncology, Waehringer Guertel 18-20, 1090 Vienna, Austria. Electronic address: daphne.gschwantler@kaulich.at.
authors.forename: D
authors.initials: D
authors.lastname: Gschwantler-Kaulich
authors.affiliation: AKH Linz Breast Cancer Center, Krankenhausstrasse 9, 4021 Linz, Austria.
authors.forename: P
authors.initials: P
authors.lastname: Schrenk
authors.affiliation: Medical University of Graz, Department of Gynaecology, Auenbruggerplatz 1, 8036 Graz, Austria.
authors.forename: V
authors.initials: V
authors.lastname: Bjelic-Radisic
authors.affiliation: Private Hospital Villach, Breast Cancer Center, Department of Gynaecology, Dr.-Walter-Hochsteiner-Straße 4, 9504 Villach, Austria.
authors.forename: K
authors.initials: K
authors.lastname: Unterrieder
authors.affiliation: Medical University of Vienna, Breast Cancer Center, Department of Gynaecological Oncology, Waehringer Guertel 18-20, 1090 Vienna, Austria.
authors.forename: C
authors.initials: C
authors.lastname: Leser
authors.affiliation: Medical University of Vienna, Breast Cancer Center, Department of Gynaecological Oncology, Waehringer Guertel 18-20, 1090 Vienna, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Fink-Retter
authors.affiliation: Otto Wagner Hospital, Department of Surgery, Baumgartner Hoehe 1, 1140 Vienna, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Salama
authors.affiliation: Medical University of Vienna, Breast Cancer Center, Department of Gynaecological Oncology, Waehringer Guertel 18-20, 1090 Vienna, Austria.
authors.forename: C
authors.initials: C
authors.lastname: Singer
mesh_terms: D062088:Acellular Dermis / Q000706:statistics & numerical data*; D001317:Austria; D018427:Breast Implants; D004954:Esthetics; D005260:Female; D006801:Humans; D016462:Mammaplasty / Q000295:instrumentation / Q000379:methods*; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D011183:Postoperative Complications; D011446:Prospective Studies; D011788:Quality of Life; D013526:Surgical Mesh; D011795:Surveys and Questionnaires
keywords: Acellular dermal matrix; Breast; Mesh; Reconstruction