The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial

Abstract

Background: Current efficacy data supporting the routine use of acellular dermal matrices in postmastectomy tissue expander/implant reconstruction are limited. A multicenter, blinded, randomized controlled study was designed to evaluate the effectiveness of acellular dermal matrix in the setting of tissue expander/implant reconstruction. The primary objective of the study was to determine whether the use of matrix would decrease patient-reported postoperative pain. The secondary objective was to determine whether its use would accelerate the rate of postoperative expansion.

Methods: The randomized controlled trial was conducted at two U.S. centers from 2008 to 2011. Immediately following mastectomy, all patients were randomized to one of two treatment arms: (1) acellular dermal matrix-assisted, tissue expander/implant reconstruction; and (2) submuscular tissue expander/implant placement. All patients were blinded to their treatment arm.

Results: One hundred eight consented to participate; 38 were excluded prior to randomization. In total, 70 patients were randomized. There were no differences seen in immediate postoperative pain (p = 0.19) or pain during the expansion phase (p = 0.65) between treatment arms. There was similarly no difference in postoperative narcotic use (p = 0.38). The rate of postoperative expansion did not differ between groups (p = 0.83).

Conclusions: The results suggest that the use of acellular dermal matrix in the setting of tissue expander/implant reconstruction neither reduces postoperative pain nor accelerates the rate of postoperative expansion. An examination of its efficacy in improving long-term outcomes following tissue expander/implant reconstruction is warranted.

Trial registration: ClinicalTrials.gov NCT00639106.

Figures

Figure 1

Two-stage eligibility confirmation and randomization

Figure 2

Flow Diagram

Figure 3

VAS scores in the ‘ADM-assisted’ and ‘Standard Approach’ cohorts over time

Figure 4

BREAST-Q Physical Well-being: Chest and Upper Body Scores in the ‘ADM-assisted’ and ‘Standard Approach’ cohorts over time