Immediate Breast Reconstruction With Acellular Dermal Matrix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-01

Study Completion Date

2016-03-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Breast Carcinoma in Situ Mammaplasty Acellular Dermis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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One-stage group

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

one-stage technique

Intervention Type PROCEDURE

breast reconstruction in one stage using silicone implant and acellular dermal matrix.

Two-stage group

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

No interventions assigned to this group

Interventions

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one-stage technique

breast reconstruction in one stage using silicone implant and acellular dermal matrix.

Intervention Type PROCEDURE

Eligibility Criteria

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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