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ABSORBABLE ANTIBACTERIAL SOFT TISSUE SUPPORT IN BREAST RECONSTRUCTION WITH INFECTION OUTCOMES ASSESSMENT ("ARIA Trial")

Primary Investigator
Momoh, Adeyiza
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT06027996
UM Number
2025.001
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Breast Oncology
ID (Protocol)
58281
Secondary Protocol No
HUM00264705
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Breast
Summary
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.

Eligibility: Inclusion Criteria
  •   * Female.
  •   * Age 22 or older at the time of enrollment.
  •   * Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.
  •   * Is able to and willing to comply with the study requirements and providing informed consent.
Exclusion Criteria
  •   * Has prior history of neoadjuvant radiotherapy.
  •   * Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
  •   * Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
  •   * Has a Body Mass Index (BMI) 14 or > 40.
  •   * Is pregnant or is nursing; or plans to become pregnant during the course of the study.
  •   * Has any connective tissue/autoimmune disorder or rheumatoid disease.
  •   * Has known allergies to study device materials.
  •   * Is participating in another interventional research study that may interfere with study endpoints.
  •   * Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
  •   * Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
  •   * Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.