Surgeon-Controlled Study and Meta-Analysis Comparing FlexHD and AlloDerm in Immediate Breast Reconstruction Outcomes

Plast Reconstr Surg. 2016 Nov;138(5):959-967. doi: 10.1097/PRS.0000000000002616.

Abstract

Background: The use of acellular dermal matrix has facilitated immediate prosthesis-based breast reconstruction. However, few studies directly compare surgical outcomes following acellular dermal matrix-based reconstruction with two of the most commonly available materials, AlloDerm and FlexHD. Those studies that are available often do not adequately control for the surgeon as a variable. The authors hypothesize that complication rates will not differ significantly between AlloDerm and FlexHD when practice and surgeon variables are properly controlled.

Methods: Retrospective review was conducted to identify consecutive implant-based reconstruction procedures performed at a tertiary academic medical institution by a single plastic surgeon over 6 years. Univariate and binomial regression analyses were conducted to compare patient characteristics and clinical endpoints across acellular dermal matrix groups (AlloDerm/AlloDerm ready-to-use versus FlexHD Pliable/Perforated).

Results: Of the 233 patients that underwent matrix-based breast reconstruction, 11 (4.7 percent) developed surgical-site infection. The infection rate was not statistically different between patients who received FlexHD [n = 5 (5.0 percent)] versus AlloDerm [n = 6 (4.6 percent)] on either univariate (p = 0.89) or binomial regression analysis (p = 0.56). Likewise, there were no statistical differences in rates of seroma, hematoma, explantation, or delayed wound healing.

Conclusions: Clinical endpoints of interest were all equivalent between acellular dermal matrix types. This study uniquely reports a single-surgeon case series comparing outcomes between different acellular dermal matrix types. Instead of focusing on acellular dermal matrix as a predictor of outcome, other patient and surgeon factors should be addressed to improve results and innovate better alternatives.

Clinical question/level of evidence: Therapeutic, III.

Publication types

  • Comparative Study
  • Meta-Analysis

MeSH terms

  • Acellular Dermis*
  • Adult
  • Breast Neoplasms / drug therapy
  • Breast Neoplasms / radiotherapy
  • Breast Neoplasms / surgery
  • Collagen / therapeutic use*
  • Combined Modality Therapy
  • Female
  • Hematoma / epidemiology
  • Hematoma / etiology
  • Humans
  • Mammaplasty / methods*
  • Mastectomy
  • Middle Aged
  • Postoperative Complications / epidemiology
  • Postoperative Complications / etiology
  • Prophylactic Mastectomy
  • Retrospective Studies
  • Seroma / epidemiology
  • Seroma / etiology
  • Surgical Wound Infection / epidemiology
  • Surgical Wound Infection / etiology
  • Treatment Outcome
  • Wound Healing

Substances

  • Alloderm
  • FlexHD
  • Collagen