This phase III trial compares the effect of prepectoral breast reconstruction with acellular dermal matrix (ADM) when compared to prepectoral breast reconstruction without the use of acellular dermal matrix in women undergoing mastectomy. Prepectoral reconstruction is a standard reconstruction technique that places the tissue expander and permanent implant in front of the chest muscles and is routinely performed in conjunction with the use of an ADM. ADM is a type of surgical mesh that is made from human or animal skin that is used for internal support during surgery and gives structure for new tissue to grow more quickly after surgery. Complications from breast reconstruction with implants includes infection, visible rippling or wrinkling of the breast implant under the skin, scar tissue, implant rupture, and other conditions that may require additional surgery. Placing an ADM in the chest during breast reconstruction may not be necessary in people who have prepectoral breast reconstruction.
Additional locations may be listed on ClinicalTrials.gov for NCT05316324.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Assess the noninferiority of prepectoral tissue expanders (TEs) breast reconstruction with acellular dermal matrix (ADM), compared with prepectoral TE breast reconstruction without ADM, in terms of rates of short-term (0-90 days) major perioperative complications (infection, reoperation, and explantation).
SECONDARY OBJECTIVES:
I. Estimate rates of minor complications (specifically seroma) after TE placement in the prepectoral plane.
II. Estimate perioperative pain, opioid use, and patient reported outcomes (PROs) after prepectoral TE breast reconstruction with or without ADM.
TERTIARY OBJECTIVES:
I. Estimate PROs and rates of 90-day major surgical complications after exchange of a TE for a permanent implant in the prepectoral plane with or without ADM.
II. Estimate rates of minor complications (specifically capsular contracture) after exchange of a TE for a permanent implant in the prepectoral plane.
OUTLINE: Treatment groups randomized to a given month and patients are assigned to the treatment group that month.
GROUP 1: Patients undergo breast reconstruction with the use of ADM.
GROUP 2: Patients undergo breast reconstruction without the use of ADM.
After completion of study intervention, patients are followed up on days 1-10, 14, 42, 90, and at 1 year.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorEvan Matros
