A trial evaluating outcomes of immediate implant-based breast reconstruction using an acellular dermal matrix (ADM) (POBRAD trial)

Prospective, open-label trial evaluating Outcomes of immediate implant-based Breast Reconstruction using an Acellular Dermal matrix (ADM) (POBRAD trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN67956295

Enrollment

Registered

2013-03-04

Start date

2011-07-20

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Cancer Malignant neoplasm of breast

Interventions

The POBRAD study aims to prospectively evaluate the complication rate, clinical and cosmetic outcome together with the cost-benefit analysis of the use of an acellular dermal matrix (ADM) for immediat

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Any person older than 18 years of age meeting the inclusion criteria are eligible to the study 2. All post-mastectomy patients undergoing immediate implant-based, breast reconstruction requiring lower pole cover

Exclusion criteria

Exclusion criteria: 1. Significant co-morbidities 2. Body mass index (BMI) >40 3. Locally advanced and/ or inflammatory breast cancer 4. Patients unable to provide informed consent to participate in trial

Design outcomes

Primary

Measure	Time frame
1. Mastectomy-site complication rate 2. Implant-related complication rate 3. Return to theatre rate Measured 1, 3 and 12 months post surgery	—

Secondary

Measure	Time frame
1. Cosmetic outcome 2. Patient reported outcome 3. Cost-benefit analysis	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026