BACKGROUND: With the increased use of acellular dermal matrix (ADM) in breast reconstruction, the number of available materials has increased. There is relative paucity of high-quality outcomes data for use of different ADMs. OBJECTIVES: The goal of this study is to compare the outcomes between a human (HADM) and a bovine ADM (BADM) in implant-based breast reconstruction. METHODS: We conducted a prospective, single-blinded, randomized controlled trial to evaluate differences in outcomes between HADM and BADM for patients undergoing immediate tissue expander breast reconstruction. We excluded patients with prior radiation to the index breast. Patient and surgical characteristics were collected and analyzed. RESULTS:From April 2011 to June 2016, a total of 90 patients were randomized to a mesh group, with 68 patients [HADM, 36 patients (55 breasts); BADM, 32 patients (48 breasts)] included in the final analysis. Baseline characteristics were similar between the two groups. No significant differences in overall complication rates were identified between HADM (n=14, 25%) and BADM (n= 13, 27%); p=0.85. Similar trends were identified for major complications and complications requiring reoperation. Tissue expander loss was identified in 7% of HADM (n=4), and 17% of BADM group (n=8), p=0.14. CONCLUSIONS: We demonstrated similar complication and implant loss rates among patients undergoing immediate tissue expander breast reconstruction using HADM or BADM. Regardless of what material is used, careful patient selection and counseling, and cost consideration help to improve outcomes and sustainability in immediate breast reconstruction.
RCT Entities:
BACKGROUND: With the increased use of acellular dermal matrix (ADM) in breast reconstruction, the number of available materials has increased. There is relative paucity of high-quality outcomes data for use of different ADMs. OBJECTIVES: The goal of this study is to compare the outcomes between a human (HADM) and a bovine ADM (BADM) in implant-based breast reconstruction. METHODS: We conducted a prospective, single-blinded, randomized controlled trial to evaluate differences in outcomes between HADM and BADM for patients undergoing immediate tissue expander breast reconstruction. We excluded patients with prior radiation to the index breast. Patient and surgical characteristics were collected and analyzed. RESULTS: From April 2011 to June 2016, a total of 90 patients were randomized to a mesh group, with 68 patients [HADM, 36 patients (55 breasts); BADM, 32 patients (48 breasts)] included in the final analysis. Baseline characteristics were similar between the two groups. No significant differences in overall complication rates were identified between HADM (n=14, 25%) and BADM (n= 13, 27%); p=0.85. Similar trends were identified for major complications and complications requiring reoperation. Tissue expander loss was identified in 7% of HADM (n=4), and 17% of BADM group (n=8), p=0.14. CONCLUSIONS: We demonstrated similar complication and implant loss rates among patients undergoing immediate tissue expander breast reconstruction using HADM or BADM. Regardless of what material is used, careful patient selection and counseling, and cost consideration help to improve outcomes and sustainability in immediate breast reconstruction.
Authors: Nikhil Sobti; Neel Vishwanath; Victor A King; Vinay Rao; Ben Rhee; Carole S L Spake; Mimi R Borrelli; Ronald A Akiki; Karl H Breuing Journal: Plast Reconstr Surg Glob Open Date: 2022-09-28