Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
NCT ID: NCT02775409
Last Updated: 2021-12-30
Study Results
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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COMPLETED
NA
200 participants
INTERVENTIONAL
2016-05-01
2020-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subcutaneous
Subcutaneous placement of tissue expander
Subcutaneous placement
The tissue expander will be placed above the muscle.
Submuscular
Submuscular placement of tissue expander
Submuscular placement
The tissue expander will be placed below the muscle
Interventions
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Subcutaneous placement
The tissue expander will be placed above the muscle.
Submuscular placement
The tissue expander will be placed below the muscle
Eligibility Criteria
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Inclusion Criteria
2. Women at least 18 years of age, who will undergo immediate bilateral implant-based breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy.
Exclusion Criteria
2. Patients desiring autologous reconstruction.
3. BMI \>40.
4. History of radiation therapy to the breast(s), e.g. history of breast conservation therapy.
5. Current nicotine and/or tobacco use.
6. Documented diagnosis of chronic pain.
7. Women who are pregnant or breast-feeding \*
8. Women who decline the use of acellular dermal matrix (ADM).
9. Surgeon decision not to proceed with tissue expander reconstruction.
10. Women undergoing single stage (straight to implant) reconstruction.
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Minh-Doan Nguyen
Assistant Professor of Plastic Surgery
Principal Investigators
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Minh-Doan Nguyen, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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16-000539
Identifier Type: -
Identifier Source: org_study_id