Immediate Breast Reconstruction With Acellular Dermal Matrix

Aarhus University Hospital

Status: Completed

Conditions: Breast Cancer; Breast Carcinoma in Situ; Mammaplasty; Acellular Dermis

Treatments: Procedure: one-stage technique

Study type: Observational

Funder types: Other

Identifiers

NCT04209010

VEK 1-10-72-572-12

Details and patient eligibility

About

The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer
• Mastectomy weight ≤ 600 g
• Patient older than 18 years
• Ability to complete the study questionnaire
• Only for the two-stage group no later than 2 years and 4 months from breast reconstruction

Exclusion criteria

• smokers

Trial design

44 participants in 2 patient groups

One-stage group

Description:

Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix.

Treatment:

Procedure: one-stage technique

Two-stage group

Description:

Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique.