Table 1.

Inclusion and Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

• Willing and able to provide written informed consent • Aged ≥21 y • Undergoing simple unilateral mastectomy, with or without sentinel node biopsy and who would otherwise be receiving surgical drains as part of standard of care • Received PACT device

• Patients with known sensitivity to ovine (sheep)-derived material, silicon, barium sulfate, or synthetic suture materials • Pregnant or lactating women • Patients on steroids or other immune modulators known to impact healing • Patients who are likely to not complete the study • Patients who, in the opinion of the investigator, are unlikely to comply with the protocol • Patients who have participated in this trial previously and who were withdrawn • Any medical condition, recent treatment, or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study, such as obesity (BMI > 40 kg/m2), uncontrolled diabetes (HbA1c > 53 mmol/mol), immunosuppression, or recent neoadjuvant chemotherapy or radiotherapy • Patient is currently participating in or has participated in another clinical study within the past 30 d before enrollment • Any patient who, at the discretion of the investigators, is not suitable for inclusion in the study • Planned axillary lymph node dissection

BMI, body mass index; HbA1c, glycated hemoglobin.